Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Treatment decision is at the discretion of the investigator and must not be made on the basis of this observational study. Patients should have their treatment initiated in accordance with the summary of product characteristics.

Dasatinib discontinuation

Michele Baccarani, Pr.

The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases.

The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.

The primary objective is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients. Imatinib mesylate, a protein tyrosine kinase inhibitor (TKI) targeting BCR-ABL, has become in the last decade the standard of care for Chronic Myeloid Leukaemia (CML) in chronic phase (CP)1-3. Dasatinib is a second generation TKI, effective in imatinib-resistant and imatinib-intolerant patients, which demonstrated superior efficacy to imatinib in early CP BCR-ABL+ CML patients 4,6,7. Most data on second generation TKIs are from company-sponsored studies, generally implemented in selected referral centres. The long-term outcome is still unknown. The high rate of study discontinuation observed within the phase 3 study may influence the mid-term and the long-term data interpretation6,7. A long-term post-marketing surveillance in large independent trial is extremely important to confirm the feasibility of a frontline treatment with the second generation TKI dasatinib and to evaluate the efficacy in a nationwide experience. Moreover, obtaining a deep molecular response is extremely relevant in order to consider TKIs discontinuation. This condition is known as "Complete Molecular Response" (CMR) and is further defined according to the sensitivity achieved (for the definition see the "Criteria of evaluation" section). As far as treatment discontinuation, two experiences have been published so far, aimed at evaluating the persistence of the CMR after imatinib discontinuation. The first was a pilot study32 where 12 patients were included. These 12 patients discontinued imatinib after at least 2 years of CMR (median duration of negativity, 32 months). Six patients displayed a molecular relapse with a detectable BCR-ABL transcript at 1, 2, 3, 4, and 5 months. Imatinib was then reintroduced and led to a novel molecular response. Six other patients (50%) still have an undetectable level of BCR-ABL transcript after a median follow-up of 18 months (range, 9-24 months). The results of this pilot trial have been confirmed and extended in a second trial, the STIM trial33: 100 patients were enrolled, median follow-up 17 months, 69 patients with at least 12 months follow-up: 42 (61%) of these 69 patients relapsed (40 before 6 months, one patient at month 7, and one at month 19). At 12 months, the probability of persistent CMR for these 69 patients was 41% (95% CI 29-52). All patients who relapsed responded to reintroduction of imatinib. An increase of the CMR rate could possibly translate in a higher proportion of patients candidate to stopping anti-CML treatment, with higher probability of remaining disease-free in the long term. Interestingly, dasatinib was able to induce higher 36-month cumulative MR4 and MR4.5 rates than imatinib7. The advantages of this possible future scenario could be: first, the possibility of treatment discontinuation at least in patients with chronic clinical adverse events; second, a potential reduction of the costs of TKI treatment (after the introduction of TKI, the costs of CML treatment is increasing year by year, with the increasing prevalence of CML patients).

In summary, 1) Most data on second generation TKIs are from company-sponsored studies; 2) The high rate of study discontinuation observed within the phase III study may influence the data interpretation; 3) A long-term post-marketing surveillance in large independent trial is extremely important to confirm the efficacy in a nationwide experience; 4) The persistence of CMR after TKI discontinuation have been described in selected patients with "deep" molecular response; 5) A stable CMR is a pre-requisite for treatment discontinuation; 6) A detailed description of the kinetic of the molecular response, potentially related to a subsequent treatment discontinuation, will be done.

Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib

Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib. An Observational Multicentric Study.

The cumulative rate of dasatinib permanent discontinuation by 2 years.

The cumulative rate of dasatinib permanent discontinuation by 5 years.

The rate of confirmed MR4 and MR4.5 by 24 months.

The rate of confirmed MR4 and MR4.5 by 60 months.

The rate of Complete Cytogenetic Response (CCgR) at 1 year.

The rate of Major Molecular Response (MMR) at 1 year.

The median time to response and the overall estimated probability of response (CCgR, MMR, MR4, MR4.5).

Overall responses and long-term outcome according to baseline prognostic factors (including: Sokal score34, Euro score35 and EUTOS score36; presence of additional chromosomal abnormalities in Ph+ cells; BCR-ABL transcript type; comorbidity score index).

Overall responses and long-term outcome according to BCR-ABL transcript levels and CgR at 3 months and at 6 months.

Fasting glucose modifications (diabetic and normo-glycemic patients) and HbA1C modifications (diabetic patients only) during the first 24 months.

Modifications of body mass index during treatment compared to baseline.

Modifications of serum lipids during treatment compared to baseline.

Gruppo Italiano Malattie EMatologiche dell'Adulto

Digestive System Diseases

Polyps

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 0. (Margin Clear \>0mm from the diathermy margin and Sm1/2 or Haggitt 1/2/3) Six monthly follow up from date of surgery.

MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to receive radiotherapy (RT) and regular surveillance, with 3 monthly follow-up from the date of surgery.

MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to surveillance arm with regular surveillance, with 3 monthly follow-up from the date of surgery.

MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of \>2. (Margin positive - 0mm to the diathermy margin, Margin positive/or unassessable due to piecemeal removal - 0mm to the tumour margin, Sm3 or Haggitt 4, Poorly differentiated/mucinous, LVI, T2) Patient is considered for surgery, receives radiotherapy and surveillance, with 3 monthly follow-up from date of surgery.

For patients where it is considered technically feasible to do LE but MR staged\<1mm muscularis preserved, or it is considered not feasible to perform a local excision. Patients undergo TME surgery. Pathology assessment on sample with confirmation of adenocarcinoma. Patient receives 6 monthly follow-up from date of surgery.

Surveillance 6 monthly

Radiotherapy and surveillance

surveillance 3 montly

Gina Brown

Xian van Gelder

This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.

The national bowel cancer screening programme (BCSP) has shown an increase in detection rates of early rectal cancer (ERC). This is treated effectively with radical surgery, offering excellent oncological outcome, but has a major impact on patient quality of life. The diagnosis of early stage rectal cancer, allows an opportunity for effective oncological treatment, with preservation of the rectum avoiding the deleterious effects of unselective use of radical surgery and unselected use of radiotherapy. Our previous work has led to High-Spatial-Resolution magnetic resonance imaging (MRI) as the established modality for providing reliable information about extramural disease prior to radical surgery.

This trial will use a new MRI staging protocol to identify more patients with early rectal cancer to enable accurate mapping for more precise patient selection for local excision. Improved success with local excision will result in greater rates of organ preservation.

Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.

Demonstrate a change in rectal preservation rates in patients with pT1 and pT2 tumours.

To measure the accuracy of MRI T staging when compared with pathology.

Report on rates of missed lesions suitable for local excision.

Report on rates of lesions not feasible for local excision

Compare costs to the NHS/other healthcare systems of major surgery versus local excision for pT1/T2 ERC.

Measure impacts of local excision and rectal preservation on patient reported quality of life outcome measures compared with stage matched patients undergoing major surgery due to patient choice or technical inability to undertake locale scission. Measurement tools used for assessment are the LARS (low anterior resection syndrome) score, the EQ-5D and Stoma Care Quality of Life Questionnaire.

Put in a separate point saying: Measure survival rates at 1 year post surgery / local excision.

To assess the quality of local excision surgery, using review of pathology slides and reports, commenting on completeness of excision, excision margins and en bloc manner of resection (local excision specimens).

Assess patient willingness to be randomised by qualitative questionnaire

Pelican Cancer Foundation

Royal Marsden NHS Foundation Trust

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Head and Neck Neoplasms

Uterine Cervical Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vinorelbine

Immunomodulating Agents

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Patients presenting advanced refractory breast cancer

Patients presenting advanced refractory head and neck cancer

Patients presenting advanced refractory cervix cancer

Patients presenting advanced refractory prostate cancer

Patients presenting advanced refractory solid tumour with high mutational load

Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy

Durvalumab + Tremelimumab + metronomic Vinorelbine

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.

Methodology:

The study divided in two parts:

* Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy,
* Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.

Indication:

Patient eligible to the study are patients with histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours: head and neck, prostate, cervix, and breast cancers, as well as miscellaneous malignancies with high mutational load.

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study divided in two parts:

* Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy,
* Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour

National Cancer Institute, France

AstraZeneca

Pierre Fabre Laboratories

UNICANCER

Participants in the study will receive training in using the ePRIME system to report their symptoms and side effects on a weekly basis from home via the internet for 12 weeks while receiving early phase trial treatment. Patients will be sent email/text reminders to enter their symptoms on the system once a week. Patients will be reminded that the data they enter via the online system will not be reviewed promptly by their hospital team and therefore they should continue to contact their treatment team via the contact numbers they have been given.

As part of the research project, we will monitor the number of notifications for severe AE generated by the system to address concerns from the interviews conducted in the first phase of this research project that ePROs will lead to increased workload for clinicians.

ePRIME is an online system for patients to self-report symptoms and AE during cancer treatment. ePRIME allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating notifications for severe AE to the relevant clinical team and providing patient advice on managing mild and moderate AE.

ePRIME symptom monitoring tool

Galina Velikova

New treatments are continually being developed to help patients living with advanced cancer, which require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician's interpretation of patient symptoms, but a substantial body of evidence suggests clinicians miss/underestimate AEs experienced by patients. The aim of the overall project is to explore the implementation of an electronic patient-reported outcomes (ePRO) system to gather adverse events data in early phase clinical trials (EPCT) patients. In Phase 1 of this study, through semi-structured interviews, we explored patient, healthcare, and clinical trial staffs' views about collecting electronic patient-reported outcomes in this setting. This work informed the direction of the current pilot. This proof-of-principle feasibility study will explore the feasibility and satisfaction with using an electronic system to remotely self-report AEs whilst on EPCT. The key objectives are to:

1. Evaluate the feasibility of using a secure online method (ePRIME system) to collect PRO-AEs in EPCT patients.
2. Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in EPCT patients.
3. Monitor the number of notifications for severe AEs generated by the system to address concerns from the interviews that ePROs will lead to increased workload.

To this end, a prospective longitudinal pilot will be conducted of the ePRIME system in early phase clinical trial patients in Leeds and Sheffield. A convenience sample of patients enrolled in Phase I or Phase II trials will be recruited. Patients in general oncology and haematology clinics will be included if diagnosed with metastatic or progressive disease and are presently receiving novel agents in an academic early phase clinical trial, such as chemotherapy, targeted agents, or chemo-radiotherapy. Patients will be included in this pilot whether the trial is a test of a novel drug, drug combination, or dose escalation. The study will aim to identify, approach, and consent all eligible patients over a minimum of a 12 month period. If they are over 18, able to give informed consent, have access to internet via any device, and able to read and understand English. Patients will be approached and consented within 1 month of having been entered in the clinical trial. Patients will not be eligible if they will be on the clinical trial for less than 3 months. Each patient will complete a patient-reported AE checklist at baseline (i.e. time of consent) and then weekly for 12 weeks. At the end of the 12 weeks an end-of-study interview will be conducted to explore patient satisfaction with the system. It is envisaged that this project will provide initial information on the feasibility and acceptability of a novel electronic system to facilitate the collection of patient-reported AEs in early phase trials.

ePRIME: Patient-Reported AEs in Early Phase Trials

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences (ePRIME): Collection of Patient-reported Adverse Events in Early Phase Clinical Trials in Yorkshire

Feasibility of using a secure, online system to record, monitor, and help patients report AEs. It will be measured through:

* the number of participants consenting versus declining;
* compliance with the ePRIME trial through the number of missed completions, out of the 12 weeks (minimum) prompted by the research team;
* number and timing of participant withdrawals and reasons;
* number of completions in addition to the weekly prompts;
* number of completions that generate notifications to the early phase clinical trials ePRIME email address.

We will explore participant satisfaction with the use of the system. Through an end-of-study interview with patients and healthcare professionals we will explore the perceived burden, barriers, and opportunities and benefits of using the novel system. In addition to this, we will also explore system usability parameters such as time of log-on and log-off, time taken to complete the measures, time outs, and time spent on each page/section.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib	NCT01761890	Chronic Myeloid...	Dasatinib disco...	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.	NCT04103372	Rectal Cancer	Surveillance 6 ... Radiotherapy an... surveillance 3 ...	18 Years -	Royal Marsden NHS Foundation Trust
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours	NCT03518606	Advanced Solid ... Breast Cancer Head and Neck C... Cervix Cancer Prostate Cancer	Durvalumab + Tr...	18 Years -	UNICANCER
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours	NCT03518606	Advanced Solid ... Breast Cancer Head and Neck C... Cervix Cancer Prostate Cancer	Durvalumab + Tr...	18 Years -	UNICANCER
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.	NCT04103372	Rectal Cancer	Surveillance 6 ... Radiotherapy an... surveillance 3 ...	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for early phase

Every month we try and update this database with for early phase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for early phase

Every month we try and update this database with for early phase cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for early phase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.