Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Dysgeusia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Taste Disorders

Sensation Disorders

Neurologic Manifestations

Quality of Life

Lymphosarcoma

Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes.

The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate a minimum of 2 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation.

Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.

The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat.

The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.

Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study.

A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes.

Multifactorial sensory rehabilitation workshops

The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat.

The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.

Usual care

fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients

Tests and Questionnaire

Franciane PAUL, Dr.

Estelle GUERDOUX-NINOT, PhD

Franciane PAUL, Dr

Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for Haematological Cancer, and also improve their life quality, psychological well-being, and nutrition.

Disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. In hematology, dysgeusia depends on the type pathology and the treatments themselves. It impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients.

Olfactory-taste disorders can be assessed using subjective and objective tests. There are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. Also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. It will help fill gaps in the assessment and management of patients treated for Haematological cancer.

Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Chemotherapy for Haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.

Ramdonized, controlled study with 2 parallel arms (interventional and control). Patients in the interventional arm will follow a multi-factor sensory rehabilitation program focused on smell and taste with daily use (3 times a day) of Liposomal sprays (LipoSaliva® : mouth and LipoNasal® : nose) between V0 and V1.

The control group will only receive the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional care.

Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer

Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of ≤ 15 for anosmia, ≥ for normonosmia and hypoanosmia for a score between 15 and 30)

Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, \<19 for women and \<17 for men; for participants aged 41 to 60, score \<15 for women and 9 for men; for participants over 60, score \<10.2 for women and \<9 for men

Variation of the taste and Smell Survey score

Quality of life scores, obtained on the FACT-G scale. This is a 27-point self-administered questionnaire that measures the quality of life of patients with cancer. The FACT-G measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment.

The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions.

assessed by the score at GPAQ scale (Bull, Maslin, \& Armstrong, 2009)

assessed by BMI between the beginning and the end of the study

University Hospital, Montpellier

Hematologic Neoplasms

Four infusions of CTM-N2D at escalating doses: 1x10\^7, 1x10\^8, 3x10\^8 or 1x10\^9 per infusion at an interval of one infusion every 7 days.

Four infusions of CTM-N2D at the optimal dose (expected to be 1x10\^9) at an interval of one infusion every 7 days.

In the production of CTM-N2D, blood cells from healthy donors are used as starting materials. Through a proprietary expansion technology, γδ T cells of high-purity can be obtained. These γδ T cells are further grafted with NKG2DL-targeting CARs using mRNA electroporation to enhance its anticancer potency. The finished product (CTM-N2D) are then infused allogeneically into cancer patients.

Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)

Raghav Sundar, Dr

Wee Kiat Tan, Dr

Raghav Sundar

Raghav Sundar, MBBS

Jieming Zeng, Dr

CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells.

Currently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy.

CytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not.

The phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D.

CTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.

Study Drug

The study treatment uses allogeneic NKG2DL-targeting CAR-grafted γδ T cells (also known as CTM-N2D). The treatment a) targets multiple stressed-induced cancer antigens (via the built-in receptors on γδ T cells, e.g., γδ TCR, NKG2D, DNAM-1); and (b) targets eight known NKG2DLs e.g., MICA/B, ULBP1-6 (via the grafted NKG2DL-targeting CAR). In humans, NKG2DLs are identified as MICA/B and ULBP1-6. Many tumour cell lines and primary tumours of various tissue-origins express NKG2DLs, providing attractive targets for CTM-N2D therapy

CTM-N2D refers to allogeneic γδ T cells that express CARs containing an extracellular domain of NKG2D as binding unit. CTM-N2D is manufactured from peripheral blood mononuclear cells (PBMCs) of allogeneic healthy donors through γδ T cell expansion and mRNA electroporation.

CTM-N2D will be packaged in an infusion bag to contain up to 1x10\^9 cells in 100ml of infusible solution (saline with 5% human serum albumin) and delivered to the clinical site on the day of planned infusion. The transportation temperature will be maintained at 2 - 8°C.

Study Design

This is a two-cohort phase I study. In cohort 1 (intrapatient dose-escalation cohort), the subjects will be given four infusions of CTM-N2D at escalating doses: 1x10\^7, 1x10\^8, 3x10\^8 or 1x10\^9 per infusion at an interval of one infusion every 7 days. This is to discern an optimal dose. In cohort 2 (optimal dose cohort), the subjects will be given four infusions of CTM-N2D at the optimal dose, which are given at an interval of one infusion every 7 days. This is to further confirm safety and tolerability.

If no DLT is detected in the first 3 patients in cohort 1, recruitment for cohort 2 will commence, with 6 patients to be treated with four doses of CTM-N2D at 1x10\^9/infusion.

Patients in the intrapatient dose-escalation cohort will be treated in sequence for the first four doses (i.e., only after all first four doses are administered for the first patient, will therapy for the second patient be allowed to commence). Such restriction is not extended to the maintenance doses. In the optimal dose cohort, 3 patients will be recruited, treated, and observed for DLT first, before another 3 patients are recruited. If 0/6 or 1/6 DLT is seen in the optimal dose cohort, the optimal dose will be established as RP2D.

If the patients do not demonstrate progressive disease after the first 4 doses of CTM-N2D and after the first imaging at 2 months from the start of study treatment (i.e., C1:1D1), maintenance doses of CTM-N2D will be manufactured and administered once every 2 months for a maximum of 5 doses. A computed tomography (CT) scan (or other forms of radiological assessment deemed appropriate by the investigator) will be performed every 2 months to evaluate stability (or response) of disease before manufacturing (a 20-day process) and administering each maintenance dose.

Treatment with CTM-N2D beyond 5 maintenance doses will be contingent to discussion with Sponsor and PI. Treatments with maintenance doses of CTM-N2D will not be considered in determining DLT.

Study Procedures and Assessments

Once informed consent is obtained and subject eligibility is confirmed, CytoMed will schedule and plan the manufacturing of CTM-N2D for the given subject.

The treatment regimen begins with lymphodepletion using Fludarabine and Cyclophosphamide to precondition the patient before the first treatment cycle with four weekly doses of CTM-N2D. Zoledronic acid will be given one day before each CTM-N2D infusion to maximize the potency of CTM-N2D.mTrial subjects will receive CTM-N2D by i.v infusion. To further enhance the survival of CTM-N2D, a dose of 1x10\^6 IU/m2 IL-2 will be injected subcutaneously within 2 hours after each CTM-N2D infusion.

Clinical assessments will be performed at specified timepoints as written in the protocol. Any other relevant laboratory/imaging evaluations can be performed at any point in time, as deemed appropriate by the site investigator(s).

To assess patient well-being after CTM-N2D infusion as well as to monitor the pharmacokinetics and bioactivities of CTM-N2D, blood samples will be collected from trial subjects at various time points throughout the study period. Other blood investigations are to be performed at the clinical site as scheduled in the trial protocol and according to institutional guidelines. Additional laboratory investigations may be performed at the discretion of the investigator.

Assessments of tumour at specified timepoints, and are to be reported by a dedicated, independent radiologist, in accordance with RECIST criteria version 1.1. Other imaging modalities may be considered at the discretion of the investigator.

Off-study Follow-up and Assessments

In the event CTM-N2D therapy is discontinued due to PD or unacceptable AE, off-study follow-up and assessments will be performed up to 14 days from the date the subject is removed from the study.

If the trial subject is removed from the study due to unacceptable AE, the AE should be followed for at least 28 days from the last dose of study treatment until the AE is stabilized, or until the initiation of other anti-tumour therapy as off-study treatment, whichever comes first.

Post-study Follow-up and Procedures

Trial subjects will be followed for survival status, at the discretion of the investigator, from the end of the study until their death, or for a period of up to 48 months after the last patient was initiated for study treatment, whichever occurs first.

Discontinuation Visit and Procedures

Upon voluntary withdrawal from the study, trial subject will still be given the option to continue scheduled evaluations, as well as, to complete an end of study evaluation. Appropriate medical care will continue to be meted out by the clinicians at the study site.

Safety, Adverse Events and Toxicity Management

Safety of the study treatment regimen will be assessed by monitoring and recording any toxicities or Aes appeared in trial subjects during the study period. The descriptions of Aes and their grading scales found in the NCI CTCAE v5.0 will be utilized for AE reporting.

Reporting of Events

The investigator is expected to collect, record, and report the "Unanticipated Problems Involving Risk to Subjects or Others" ("UPIRTSO") events in the study to the NHG Domain Specific Review Boards (DSRB). The criteria for UPIRTSO events and their timeline for reporting to NHG DSRB are defined in the protocol.

Reporting of SAEs to HSA

The investigator is expected to collect, record and report SAEs to the Health Science Authority (HSA) through CytoMed Therapeutics Pte Ltd. All SAEs that are unexpected and related to the study drug will be reported to HSA.

All SAEs that are unexpected and related to the study drug will be reported. The investigator is responsible for informing CytoMed Therapeutics Pte Ltd within 24 hours after first knowledge that the case qualifies for expedited reporting. CytoMed Therapeutics Pte Ltd will report the SAEs to HSA no later than 15 calendar days upon receiving SAE reports from the investigator. Follow-information will be actively sought and submitted as it becomes available. For fatal or life-threatening cases, HSA will be notified as soon as possible but no later than 7 calendar days after first knowledge that a case qualifies, followed by a complete report within 8 additional calendar days.

Safety Monitoring Plan

The investigator is responsible for appropriate medical care of subjects during the study. The investigator will review all patients to monitor toxicity before each treatment cycle. If a subject reports an AE, appropriate care and follow-up evaluation should be implemented by the investigator until the event is either resolved or stable.

An independent Data Safety Monitoring Board (iDSMB) formed by experts with relevant knowledge of the study will monitor the safety aspect of this trial. The board will review the safety data after completion of each cohort and/or if a DLT occurs.

Dose-limiting Toxicities (DLTs)

DLT is defined as an unexpected grade 3 or 4 non-hematologic toxicity that is probably related to CTM-N2D infusion and experienced within 8 weeks immediately after the start of study treatment (i.e., C1:1D1). Treatments with maintenance doses of CTM-N2D will not be considered in determining DLT. The criteria for DLT is defined in the protocol.

Whenever a patient experiences toxicity that fulfil the criteria for a DLT, the study treatment will be interrupted. The investigator is responsible for reporting DLT observed by the investigator to the sponsor within 24 hours of learning of its occurrence.

Toxicity Management

Current CAR-T cell therapy has been used to treat B-cell malignancies and multiple myeloma. The clinical experiences from these trials show that potential severe toxicities are not uncommon. Such potential severe toxicities in CAR-T therapy include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), on-target off-tumour toxicity, tumour lysis syndrome (TLS) and immunogenicity.

The grading and management of potential CAR-T toxicities follow a grading system proposed by the American Society for Transplantation and Cellular Therapy (ASTCT; formerly American Society for Blood and Marrow Transplantation, ASBMT). However, institution practices and sub-specialty input will prevail and supersede this protocol if necessary.

A specific concern for CTM-N2D treatment is the potential "on-target off-cancer" toxicity. CTM-N2D targets NKG2D ligands, which may be upregulated in non-cancer cells upon infection, inflammation, or stress. The recognition of the non-cancer cells by CTM-N2D may cause CRS and autoimmune toxicity. Subjects will also monitored for Tumour lysis syndrome (TLS).

Subject Withdrawal

Subjects have the right to withdraw from the study at any time and for any reason, without prejudice to their future medical care by the investigator or at the institution. Subjects who do not complete the study protocol will be considered to have prematurely discontinued study. The reasons for premature discontinuation (for example, voluntary withdrawal, toxicity, death) must be recorded on the case report form. Final study evaluations will be completed at the time of discontinuation.

The investigator and/or sponsor can also decide to withdraw a subject from the investigational product and/or other protocol-required therapies, protocol procedures, or the study as a whole or at any time prior to study completion.

Study Monitoring

The principal investigator is responsible for familiarising the investigator(s) and the entire study team involved in the study with all study procedures, including the administration of the study drug. The investigators are responsible for monitoring the safety of subjects who have enrolled for this study and for alerting the principal investigator to any event that seems unusual, even if this event may be considered an unanticipated benefit to the subject. The investigators are responsible for appropriate medical care of subjects throughout the study period.

In the event of SAEs, or Aes that result in any subject(s) withdrawing from the study, the investigators remain responsible for the care and followup of the subject(s), until the AE resolves, stabilizes or is explained.

Data collection and analysis

Data are recorded and stored on an electronic data capturing system called Redcap. CRFs will be translated to SPSS and Excel spreadsheets for further analysis. ANOVA multivariate analysis will be used to determine statistical significance of continuous variables. Chi-square and Fisher's exact test will be used to assess associations between categorical variables.

Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers

A Phase I Trial to Evaluate Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) in Subjects With Advanced Solid Tumours or Haematological Malignancies

Cohort 1: Three patients will be treated with four escalating doses of CTM-N2D to determine an optimal dose based on the incidence of DLT. DLT is defined as an unexpected grade 3 or 4 non-hematologic toxicity that is probably related to CTMN2D infusion and experienced within 8 weeks immediately after the start of study treatment. Treatments with maintenance doses of CTM-N2D will not be considered in determining DLT.

Cohort 2: Six patients will be treated with four infusions of CTM-N2D at the optimal dose determined in Cohort 1.

Trial subjects will be followed for survival status, at the discretion of the investigator, from the end of the study until their death, or for a period of up to 48 months after the last patient was initiated for study treatment, whichever occurs first.

National University Hospital, Singapore

CytoMed Therapeutics Pte Ltd

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphatic Diseases

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Amino Acids

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Acalabrutinib

Rituximab

Vincristine

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Prednisone

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) immunochemotherapy every 21 days.

1 cycle of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) immunochemotherapy followed by 5 cycles of R-CHOP + acalabrutinib taken twice daily for 21 day cycles.

Arm A patients will receive R-CHOP alone.

R-CHOP

Arm B patients will receive R-CHOP in combination with acalabrutinib.

R-CHOP + acalabrutinib

Nicole Keyworth

Joshua Caddy

Andrew Davies

This study evaluates the addition of Acalabrutinib to current standard therapy of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) for patients with previously untreated CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) requiring full course chemoimmunotherapy.

All patients will receive one cycle of R-CHOP. Two thirds of patients (Arm B) will go on to receive a further 5 cycles (every 21 days) of R-CHOP with Acalabrutinib. Acalabrutinib will be taken orally twice daily continuously in 21 day cycles.

One third of patients (Arm A) will continue with 5 cycles of R-CHOP.

Patients will be followed up initially for 24 months and then for disease status and survival until 114 progression events have been observed.

Diffuse large B-cell lymphoma (DLBCL) is the most common of the non-Hodgkin's lymphomas. Whilst the majority of patients will respond well to conventional treatment (R-CHOP - rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone), a significant number of patients lymphoma will not respond to initial therapy or their disease will return after completion of therapy. In a number of B-cell diseases an enzyme called, Bruton tyrosine kinase (BTK) prevents death of tumour cells, including in DLBCL. Acalabrutinib is an orally active BTK-inhibitor and it is thought that stopping BTK being activated may help in treating B-cell diseases. It is hypothesised that the addition of Acalabrutinib to standard R-CHOP immunochemotherapy may improve outcomes of patients with DLBCL.

REMoDL-A is a randomised, phase II, open label, multicentre study that will be open in up to 50 centres. Up to 553 patients (453 randomised) will be recruited.

Following informed consent all patients will receive 1 cycle of conventional R-CHOP chemotherapy. At the same time the diagnostic pathology block will be sent for molecular profiling by the Haematological Malignancy Diagnostic Service (HMDS). The delivery of the first cycle of R-CHOP will allow a sufficient interval for real time determination of molecular phenotype. Patients whose biopsies yield sufficient tumour material for profiling will be randomised 2:1 in favour of the experimental arm (R-CHOP + acalabrutinib).

The primary objective will be to establish if combining acalabrutinib with R-CHOP improves efficacy, compared to R-CHOP alone, for the treatment of previously untreated patients with DLBCL to a degree that justifies further development of this approach.

Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib

Applying the following techniques to FFPE tumour material: mutational panel, FISH analysis, immunohistochemical analysis for dual protein expression of Myc and Bcl2 and dynamic changes in ctDNA and methylation based ctDNA during treatment and follow up.

Tumour burden defined by metabolic tumour volume (MTV) and tumour lesion glycolysis (TLG). Bone marrow involvement defined by focal uptake in the bone marrow higher than liver uptake; diffuse bone marrow uptake higher than liver uptake will be recorded and correlated with bone marrow biopsy results where available (number and location of extranodal sites).

Progression-free survival (PFS) is defined as time from registration to progression/death from any cause.

PFS interaction with cell of origin phenotype (ABC, GCB and unclassifiable).

PFS interaction with clinical variables, including for example IPI, bulk, components of IPI, age and others to be determined in the SAP.

Overall survival (OS), defined as time from registration to death from any cause.

Event-free survival (EFS), or time to treatment failure, defined as time from registration to any treatment failure including disease progression, or discontinuation of treatment for any reason.

Disease-free survival (DFS), defined as time of documentation of disease-free state to disease recurrence or death as a result of lymphoma or acute toxicity of treatment.

Time to progression (TTP), defined as time from registration until documented lymphoma progression or death as a result of lymphoma. Deaths from other causes are censored at the time of death.

Response duration (DoR), defined as the time from documentation of response until the documentation of relapse or progression.

Assessment using the Lugano Response Criteria for Malignant Lymphoma.

Evaluation of toxicity according to CTCAE version 5.

Application of the EORTC QLQ-C30 and FACT-Lym questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer	NCT04716153	Multiple Myelom... Olfactivo-gusta... Lymphoma Haematological ...	Multifactorial ... Usual care Tests and Quest...	18 Years - 75 Years	University Hospital, Montpellier
Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers	NCT05302037	Cancer Malignancy Refractory Canc... Relapsed Cancer	Allogeneic NKG2...	21 Years -	CytoMed Therapeutics Pte Ltd
Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)	NCT04546620	Diffuse Large B...	R-CHOP R-CHOP + acalab...	16 Years -	University Hospital Southampton NHS Foundation Trust

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