Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Fatigue

Quality of Life

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Titration of MTP for treatment of fatigue

Placebo

Henrik Frederiksen, MD. PhD

Henrik Frederiksen, MD, PhD

Cancer related fatigue (CRF) is the most debilitating problem for patients with haematological cancer. CRF severely reduces quality of life (QoL), functional capacity, impacts health behavior, recovery and furthermore no approved treatment exists. In solid cancer methylphenidat (MTP) has been suggested to improve CRF, however patients with haematological cancer has not been studied. The current randomized placebo controlled study includes a variety of severely fatigued haematological cancer patients from seven Danish departments. It aims at revealing whether MTP can improve CRF, functional capacity and QoL thereby hopefully providing improvement and treatment options in this field where improvements are requested the most by patients. Patients are randomized to treatment with MTP or placebo week 1-6 followed by "wash-out" and cross-over - placebo to MTP or vice versa - during week 8-13. End-points will be patient reported fatigue, as well as improvements in active hours, functional capacity, and QoL.

BACKGROUND Survival prognosis in haematological malignancies has improved considerably, however the frequency and impact of the most prevalent and debilitating symptoms - cancer related fatigue (CRF) - has not improved. Up to 40% of cancer patients has daily difficulties due to CRF and fatigue and weakness is affecting 2/3 of patients. In contrast to everyday fatigue CRF is defined as an unusual and persistent sense of tiredness, weakness, or even exhaustion that is not relieved by rest or sleep and leads to decreased physical or mental capacity.

Haematological cancer is often associated with fatigue due to both anemia and constitutional symptoms. Myeloablative chemotherapeutic regimens and stem cell transplantations are unique for haematological cancer treatment and these very potent regimens may result in CRF even after several years. CRF among haematological cancer patients is associated with reduced adherence to physicians recommendations \[11\] and permanent withdrawal from labor market. Patients express that their single most prevalent and severe problem is "dealing with feeling tired", exceeding the proportion who expresses problems "in dealing with not feeling sure that the cancer has gone" or "being told they had cancer".

An increasing emphasis has been given to rehabilitation in cancer patients and individualized exercise programs; however, these will only be feasible among a minority of haematological cancer patients. In recent years, studies using methylphenidate (MTP) in the treatment of CRF in solid cancer have been conducted, some of which have found improvements in fatigue with MTP and without significant adverse effects. These studies show that MTP may be beneficial in management of CRF. However, patients in concurrent chemotherapy were unlikely to benefit.

STUDY RATIONALE AND OBJECTIVE Patients with haematological malignancies have a severe unmet need in dealing with CRF and hardly any patients with haematological malignancies have been included in previous intervention studies. MTP treatment has been found to be safe in this setting . The current study aims at studying whether MTP can be used for management of CRF in patients with haematological cancer in order to improve also functional capacity and quality of life (QoL). Many of the patients in the current study will have no other treatment options to improve their fatigue, QoL, and functional capacity.

STUDY END-POINTS The primary end point it patient reported fatigue after six weeks of MTP treatment measured by the FACIT-F scale. A good clinical response is defined as a 25% reduction in fatigue from baseline score. Secondary end-points are changes in hours awake, in time spend at work, being social, house work / gardening, being outside, participating in exercise, in muscle strength and endurance, in QoL, and in number of blood transfusions.

STUDY POPULATION AND DESIGN The study population comprises 150 patients with haematological malignancies who are not in current chemotherapy. The patients will be included from seven haematological out-patient clinics in Denmark. The haematological out-patient clinics have a large group of chronic severely fatigued haematological cancer patients that will be approached for inclusion in the trial. Power calculations, and assumptions behind as well as a detailed list of inclusion and exclusion criteria are available from full study protocol.

Patients will be randomized (1:1) to MTP or placebo treatment for 6 weeks. After this time points patients treated with MTP will after one week wash-out cross over to placebo treatment and vice versa (Figure). The rationale for the crossover design is that the study includes a variety of different haematological malignancies with different symptomatology, course, management and different degree of bone-marrow failure. When using patients as their own controls the effects of these factors are accounted for. Treatment will be blinded to the patient, treating investigators, staff, sponsor, and study secretariat. Patients will be randomized to start either MTP or matching placebo twice daily. The dosage will start at 5 mg twice daily at 8 am and 1 pm or matching placebo and can be titrated to a maximum of 20mg twice daily or matching placebo. From day 1 in week 8 treatments will be crossed over from either MTP to placebo or vice versa (Figure).

FATIGUE AND QUALITY OF LIFE ASSESSMENT TOOLS The fatigue assessment scale - FACIT-F - has been widely used in studies of cancer related fatigue and a FACIT-F score change both as a covariate and as the main outcome measure in interventional studies. In line with us previous clinical trials used a single VAS-fatigue assessment for inclusion prior to treatment. The visual analogous scale is 100 mm long and ranges from 0 = "not tired" to 10 = "worst possible tiredness". The European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires are among the most widely used tools for assessing physical and psychosocial symptoms in cancer patients. The EORTC-QLQ-C15-PAL was developed for the palliative setting \[24\]. Permission to include the fatigue and QoL scales has been granted to the trial.

EFFICACY EVALUATION Efficacy of MTP treatment will be evaluated using FACIT-F, EORTC-QLQ-C15-Pal, VAS-F as well as patients' perception on their energy and diaries on activities. The study is powered to show a 4.25 point reduction in the FACIT-F scale (corresponding to an estimated 25% reduction from baseline) that has been suggested as a minimal important difference in studies of CRF. Assessments of functional capacity (muscle strength and endurance) as well as patients' actual daily chores are also included in this evaluation.

Methylphenidate or Placebo titrated according to effect and toxicity week 1-6 followed by 1 week of washout and then crossover followed by repeated procedures with the other treatment for week 8-13.

Identical placebo tablets are produced. Study pharmacy produces study medication containers and randomizes patients, and keeps track of unique study IDs. Unblinding is only done after completion or in emergency situations

MethylphenIdate for Fatigue in Haematological Cancer

MethylphenIdate for Fatigue in Haematological Cancer. A Randomized, Double-blind, Placebo-controlled, CROssover Trial - the MICRO Trial

Henrik Frederiksen

Professor, MD, PHD

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Gemcitabine

Rituximab

Oxaliplatin

Atezolizumab

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

Immune Checkpoint Inhibitors

6 Cycles of R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) every 14 days.

1 Cycle of R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) followed by 5 cycles of R-GemOx with Atezolizumab every 14 days.

Followed by 8 maintenance cycles of Atezolizumab every 21 days.

Intravenous drip/or Subcutaneous from cycle 2

Gemcitabine 1000 mg

Oxaliplatin 100 MG

Andy Davies

This study evaluates the addition of Atezolizumab to current therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) that are not candidates for high-dose therapy. All patients will receive one cycle of R-GemOx. Three quarters of patients (Arm B) will go on to have a further 5 cycles (every 14 days) of R-GemOx with Atezolizumab, with one quarter of patients (Arm A) continuing with 5 cycles of R-GemOx.

The patients in Arm B will continue to have Atezolizumab every 21 days for 8 cycles whilst Arm A patients will enter an observational phase during this time.

Follow up will begin at 12 months from initial treatment until month 32.

Rituximab is a chimeric mouse/human monoclonal antibody that binds to CD20, on pre-B and mature B lymphocytes and eliminates these cells potentially via a number of different mechanisms.

The R-GemOx regimen has been adopted by many sites internationally as therapy for older patients or comorbid patients with relapsed or refractory DLBCL and as a back-bone for the investigation of novel therapies in combination with chemotherapy.

The cytotoxic T-lymphocyte co-receptor PD-1 has been extensively studied and is recognised to provide critical inhibitory signals that down-regulate T-cell function and provides a mechanism for immune evasion for tumours. PD-L1, the ligand of PD-1 is expressed on DLBCL tumour cells, along with infiltrating non-malignant cells, primarily macrophages, with PD-1 expressed on tumour infiltrating lymphocytes (TILs). Atezolizumab targets programmed PD-L1 on immune and tumour cells and prevents interaction with either PD-1 receptor or B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells. Interference of the PD-L1:PD-1 and PDL1:B7.1 interactions may enhance the magnitude and quality of the tumour-specific T-cell response through increased T-cell priming, expansion, and/or effector function.

This study of atezolizumab in combination with rituximab, gemcitabine and oxaliplatin aims to address the unmet need of patients with relapsed and refractory DLBCL. It is based upon a sound mechanistic approach, investigating the activity of novel agents and will aim to compressively explore biomarkers of response.

The primary objective will be to document the durability of anti-tumour activity in patients with relapsed or refractory DLBCL and to determine the safety and toxicity profile of the combination. A maintenance phase of atezolizumab has been added as this may induce an on-going T-cell response to neo-antigens released as a result of chemotherapy.

Atezolizumab, Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory DLBCL Not Suitable for High-dose Therapy

A Phase II Study of Atezolizumab With Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Are Not Candidates for High-dose Therapy

Gene expression profiling on FFPE tumour material

immunohistochemical analysis of primary tumour material

flow cytometry of t-cells in peripheral blood collected during therapy

Application genes of NGS DLBCL mutation panel of 54 genes to tumour material

Examine translocations of Myc, Bcl6 and Bcl2 by FISH

Immunohistochemical analysis for dual protein expression on Myc and Bcl2

Plasma lymphoma nucleic acid at baseline studied and compared with paired lymphoma tissue sample and repeated throughout study period to examine dynamics of change and possible assessment of minimal residual disease, depending upon responses observed

Progression free survival will be measured from patient notes, from the day of registration to the date of progression or death from any cause. Patients who do not die will be censored at their date of last follow up.

Determining the toxicity and causality of each adverse event with R-GemOx-Atezo.

Objective response, partial or complete metabolic response, to be assessed by PET / CT according to LYRIC.

Overall survival will be measured from patient notes, from the day of registration to the date of death from any cause. Patients who do not die will be censored at their date of last follow up.

Hoffmann-La Roche

University Hospital Southampton NHS Foundation Trust

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Bortezomib

bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months

Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months

bortezomib retreatment due to relapse

Janssen Pharmaceutica N.V. Clinical Trial

The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months. During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma. Only data already mentioned in your clinical file will be collected. About 100 adult patients will take part in the study

This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responded to bortezomib as first-line treatment, experienced partial response or better, presented with relapsed disease, and were re-treated (second-line) with bortezomib (for at least 3 cycles) after a treatment-free interruption of at least 6 months. As this is a non-interventional study, no changes to the current treatment that the patient receives will be required, and no additional treatment will be provided by the company. The decision of the patients to take part in this study will not have any impact on the care they receive. All the appropriate treatment-related decisions will have been made by the treating physician(s), and only data available from clinical practice will be collected. Retrospective data will be collected at a single time point for each patient (the data collection visit). Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria. After receiving the signed informed consent form (ICF) from the patient (if required by local regulations), the investigator will start documenting the retrospective data for each patient using electronic data capture (eDC). After confirmation of the patient's eligibility, the patient's last visit, patient characteristics, predefined risk factors (if available), MM-related data, and first- and second-line bortezomib-related data will be documented in the Case Report Form (CRF). The patient's status after re-treatment with bortezomib, medical resource utilization data, as well as (serious) adverse drug reactions (\[S\]ADRs) will be collected. No blood, urine, or other biological samples will be taken, and no additional investigations will be performed. the current therapy of the patient will be maintained with no changes

Retrospective Survey of Re-treatment With Bortezomib

Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy

overall response after retreatment will be assessed from initial diagnosis to the time of data collection

number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection

duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection

duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection

number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection

outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection

safety and tolerability will be evaluated based on the collection of serious and non serious adverse drug reactions from initial diagnosis to the time of data collection

Janssen Pharmaceutica N.V., Belgium

EMEA Medical Affairs Director Oncology

Syndrome

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antibodies

Antibodies, Monoclonal

Venetoclax

Azacitidine

Decitabine

Immunoglobulins

Enzyme Inhibitors

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week.

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle.

monoclonal antibody (mAb), targeting galectin-9 protein

LYT-200

Chris Korth

Aleksandra Filipovic, MD, PhD.

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

This is an open-label, non-randomized, multi-center, Phase 1, dose escalation study in patients with AML relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant, or in patients with a documented diagnosis of relapsed/refractory, high-risk myelodysplastic syndrome (MDS) post at least one line of treatment and for whom no standard therapy that may provide clinical benefit is available. The 4+2 algorithm-based dose-escalation design will be used to help identify the recommended Phase 2 dose (RP2D). Single agent LYT-200 and in combination with venetoclax and/or hypomethylating agents (HMA) safety and tolerability evaluation is the primary study endpoint, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 single agent and in combination with venetoclax and/or HMAs are key secondary study endpoints.

A Phase 1 open-label, multi-center study. The 4+2 algorithm-based dose-escalation design in single agent LYT-200 and in combination with venetoclax and/or HMAs will be used to help identify the recommended Phase 2 dose (RP2D). Up to 6 patients per single treatment Cohorts 1-5 will receive infusions of LYT-200 every week (QW). Up to 6 patients per combination Cohorts 1-4 will receive infusions of LYT-200 QW and oral venetoclax every day and/or HMAs for 7 days (azacitidine) or 5 days (decitabine) per cycle.

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status

Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status

Evaluate preliminary efficacy of LYT- 200 as a single agent in AML and MDS

PureTech

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Aspiration

Respiration Disorders

Respiratory Tract Diseases

You will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study.

The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit).

They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program.

the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm.

You will be offered 6 coaching sessions at a rate of one session per month and the first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12. Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)

interviews with coachs, semi-structured interviews and questionnaires

The first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12.Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)

semi-structured interviews and questionnaires

Dominique GENRE, Dr

Allison ARTHUR

Didier BLAISE, Pr

To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).

After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups:

* OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group
* Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group

They will be randomized unequally (2:1) into one of the study groups

Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells

Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells : a Randomized Controlled Trial REBOND2-IPC 2022-009

evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200

evolution of the FACT-BMT(Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score up to R12 evolution over time of sub-scores related to physical well-being, social well-being, functional well-being and relationship with the physician.the quality of life is a questionnaire with scores ranging from 5 to 20

evolution over time of self-efficacy (the higher the score, the better the efficiency), capability, subjective well-being and hope scores

changes over time in HADS scores (Hospital Anxiety and Depression Scale)the highest score corresponds to high anxiety and depression the value are between 0 and 21 but if the patient has a score higher than 11, he is suffering from anxiety or depression

incremental cost-effectiveness ratio (QALYs)

evolution over time of the patient's speech (semi-directive interviews)

measure the overall survival rate at M15/R12

Institut Paoli-Calmettes

Digestive System Diseases

Lung Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with colorectal cancer who are about to start treatment. Participants will be asked to:

* Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months).
* Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-C survey).
* Report specific symptoms on an ad-hoc basis as they wish.

This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with lung cancer who are about to start treatment. Participants will be asked to:

* Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months).
* Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-L survey).
* Report specific symptoms on an ad-hoc basis as they wish.

Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to:

* Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion)
* Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days.
* Supported to take daily weights using Withings Body Scale.
* Asked to complete weekly electronic quality of life surveys
* Provide a series of 12 blood samples to measure inflammatory molecules at various intervals

All participants will be asked to wear an OURA ring and WithingsScan Watch both at home and whilst in hospital. These devices can record activity, sleep type and duration, resting heart rate and heart rate variability along with a range of other vital signs.

OURA Ring

WithingsScan Watch

Participants in cohort 3 will also be asked to wear Isansys monitoring devices whilst they are in hospital. They will begin to wear the monitors prior to CAR T-cell therapy and continue for 28 days post infusion. Participants will be asked to wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days.

Isansys Patient Status Engine

On a weekly basis participants will be asked to complete satisfaction surveys for the devices they are wearing (ring and watch) and report on their quality of life through standardised questionnaires. These surveys will be delivered electronically to participants via their smartphone or tablet device. There will be an option for participants to report adhoc symptoms via an app on their smartphone or tablet device.

Quality of Life Surveys

COHORT 3 ONLY

Participants in Cohort 3 only will be asked to provide a series of blood samples to measure inflammatory molecules during the study. These will be requested at various intervals during face-to-face visits and whilst the patient is in hospital:

* Baseline blood sample during study enrolment
* Post-lymphodepletion and prior to CAR T-cell infusion (this may be on day -1 or day 0 as needed)
* Post CAR T-cell infusion:

  * Day 1
  * Day 3
  * Day 6
  * Day 9
  * Day 14 (if the participant remains in hospital)

A sample of blood will be taken at baseline and a further sample post lymphodepletion and prior to CAR T-cell infusion. Post CAR T-cell infusion, samples will be taken at two timepoints (morning and afternoon) on each of the sampling days.

Blood Samples

COHORT 3 ONLY

During their inpatient stay, up to a maximum of 28 days, participants in Cohort 3 will be supported to weigh themselves daily using a Withings Body Scale.

Daily Weights

Hayley Brooks

Dr Anthony Wilson

The EMBRaCE-GM study is a multi-cohort trial designed to efficiently evaluate the range of wearable vital signs monitors that could be used to support patients during cancer treatment.

The aims of the study are to determine

* to determine if continuous vital signs monitoring is feasible during cancer treatment
* to determine if such monitoring is acceptable to patients undergoing cancer treatment
* to determine what insights could be made with the data obtained

A multi-cohort study is essential because there are a huge range of vital signs monitors that could be useful and a method that allows quickly identification of the devices that are most acceptable to patients and which offer the most useful information to clinicians is needed. Similarly, the best device may vary according to the specific disease and the treatment a patient is offered.

Each cohort in the study will investigate a variety of wearable vital signs monitors in different patient groups undergoing different treatments. A common data collection platform will be used for all cohorts with a modular design that allows data collection to be adapted slightly to meet specific needs for each cohort.

1 in 2 people will be diagnosed with cancer during their lifetime with over 350,000 new cancer diagnoses per year (UK). Cancer treatment is a complex process. Patients experience a range of symptoms as a consequence of their disease and their treatment. Sometimes, the treatment itself can lead to specific life-threatening complications.Patients who recover may be left with lasting physical and psychological consequences. A third of those who are suffering from cancer or who have recovered from it classify their health as 'average to poor' which is double the rate reported by individuals without health problems. There is an ongoing need to offer patients personalised support through their cancer journey and to identify and minimise complications.

This need for personalised cancer care is emphasised in the NHS Long Term Plan (2019). A key aim of which is to improve cancer survival but with a focus on giving patients 'more control over their health' through improved self-management. The long-term plan identifies a need for digitally-enabled care to empower patients and highlights that artificial intelligence (AI) and digital clinical decision support could play a role in this regard.

Wearable vital signs monitors offer a solution by which patients can be monitored more frequently and in more detail during cancer treatment. There is a huge variety of wearable monitors which range from commercially available well-being trackers to CE marked medical devices. The devices themselves take many forms which may vary in their acceptability to patients and utility to health care professionals. The parameters which can be monitored range from traditional vital signs to more holistic measures of sleep, stress and activity. Such information could help to identify individuals who are recovering well, those who are experiencing specific symptoms or those who need extra assistance.

The availability of commercial well-being monitors is growing rapidly and monitors are becoming progressively more sophisticated. Monitors are also increasingly used in medical research in conjunction with or in place of formal medical devices. This trend has been highlighted in a recent systematic review in which the authors noted the need for further research to understand the validity and acceptability of using such devices in an outpatient healthcare setting. This is particularly true for patients suffering from cancer, where the vast majority of wearable device research has focused upon exercise trackers, the breast cancer tumour type and patients who have already completed their cancer treatment. In addition, the acceptability of such devices to patients has been shown to vary. The COMPARE study reported that patients are broadly supportive of artificial intelligence (AI) and wearable devices whilst a study in patient genitourinary cancer found that acceptability of wearable devices varied between 100% (40-49 years) and 40% (80-89 years).

The situation is broadly the same for wearable vital signs monitors which are registered as medical devices. Whilst these devices have been more extensively studied, the majority of research does not pertain to cancer patients and no specific use case has been identified in this patient population.

Therefore, before wearable vital signs monitors can play a role in cancer care it is essential that the acceptability of the range of devices is formally evaluated in a variety of cancer types, in a broad demographic of patients, over the duration of cancer treatment and in a variety of treatment modalities and settings. The investigators aim to understand the potential of these devices to offer new insights and learn if the information provided can be useful to patients and healthcare professionals.

The EMBRaCE-GM study is a multi-cohort trial designed to efficiently evaluate the range of wearable vital signs monitors. Each cohort is a distinct group of patients who undertake a feasibility study.

Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

A Multi-cohort Trial to Investigate the Feasibility and Acceptability of Wearable Vital Signs Monitors in Patients Undergoing Cancer Treatment in Greater Manchester.

The proportion of participants who completed the planned duration of monitoring with the device (ie:- did not request to terminate the study early) and the amount of time vital signs were actually recorded by the device expressed as a percentage of the total time the patient wore the device on the study.

The proportion of participants who completed 5 weeks of monitoring and the full period of monitoring (hospital admission to discharge, max 28 days) with the device (i.e:- did not request to remove the device early) as the amount of time vital signs were actually recorded by the device expressed as a percentage of the total duration of the participant's planned cancer treatment.

The proportion of participants who completed 5 weeks of monitoring and the full period of monitoring (hospital admission to discharge, max 28 days) with the device (i.e:- did not request to remove the device early) as the amount of time vital signs were actually recorded by the device expressed as a percentage of the total time the patient wore the device on the study.

The number of daily weights recorded (inpatient stay, max 28 days)

The outcome is measured as an overall device acceptability to participants, this will be reflected as the number of eligible patients who declined to take part in the study and their reasons for declining compared to participant feedback of acceptability.

Participants will be asked to complete a weekly survey (via smart phone/tablet) to determine the acceptability of the devices to patients:

- Likert scale acceptability ratings for each wearable monitor(pre-defined answer options, ranging from "very likely" through to "highly unlikely" on a 5-point scale) and free text comments on wearing the devices

Participants will be asked to complete a weekly survey (via smart phone/tablet) to determine the acceptability of the devices to patients:

- The percentage of participants who report each week that they have decided to stop wearing the device (via weekly survey) and categorical reasons for device removal (via weekly survey)

Participants will be asked to complete a weekly survey (via smart phone/tablet) to determine the acceptability of the devices to patients:

- The percentage of the devices that are successfully returned for re-use at the end of the study period and for devices that were not returned, what was the reason for this?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MethylphenIdate for Fatigue in Haematological Cancer	NCT03218254	Hematological C...	Methylphenidate Placebo	18 Years -	Odense University Hospital
Atezolizumab, Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory DLBCL Not Suitable for High-dose Therapy	NCT03422523	Diffuse Large B... Relapsed Diffus... Refractory Diff...	Atezolizumab Rituximab Gemcitabine 100... Oxaliplatin 100...	16 Years -	University Hospital Southampton NHS Foundation Trust
Retrospective Survey of Re-treatment With Bortezomib	NCT01524445	Hematological C... Multiple Myelom...	bortezomib retr...	18 Years -	Janssen Pharmaceutica N.V., Belgium
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)	NCT05829226	AML, Adult Recu... MDS	LYT-200 Venetoclax Azacitidine Decitabine	18 Years -	PureTech
MethylphenIdate for Fatigue in Haematological Cancer	NCT03218254	Hematological C...	Methylphenidate Placebo	18 Years -	Odense University Hospital
Atezolizumab, Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory DLBCL Not Suitable for High-dose Therapy	NCT03422523	Diffuse Large B... Relapsed Diffus... Refractory Diff...	Atezolizumab Rituximab Gemcitabine 100... Oxaliplatin 100...	16 Years -	University Hospital Southampton NHS Foundation Trust
Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells	NCT05486273	Hematological C...	interviews with... semi-structured...	18 Years -	Institut Paoli-Calmettes
Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester	NCT05099237	Colorectal Canc... Lung Cancer Hematological C... CAR T-Cell Ther...	OURA Ring WithingsScan Wa... Isansys Patient... Quality of Life... Blood Samples Daily Weights	16 Years -	Manchester University NHS Foundation Trust
Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer	NCT03056469	Hematological C...	Completion of p...	18 Years - 100 Years	Zealand University Hospital
Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells	NCT05486273	Hematological C...	interviews with... semi-structured...	18 Years -	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for hematological cancer