NCT04670029RecruitingPhase 3
Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
Source: ClinicalTrials.gov · Last updated 8 Oct 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 inhabitants in France. The median age is 65 and a third of patients are over 75 years old. 60% of patients are cured after a standard regimen of chemotherapy with RCHOP; 40% of patients will, however, relapse. No other regimen has shown improvement in overall survival, but poor prognosis factors have been identified. Beyond these factors, other prognostic factors can impact overall and progression-free survival: sarcopenia, nutritional status disorders Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it. The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on adapted physical activity . Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology. Sarcopenia is an often-underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality. Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact. The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15% compared to the standard arm.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 9 Dec 2020
- Start date
- 8 Sept 2021
- Primary completion date
- Aug 2025
- Lead sponsor
- Weprom
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04670029
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 186
- From 8 Sept 2021 to the primary completion date, Aug 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient having received 3 or more cycles of 1st line chemotherapy,
Other illness
- Uncontrolled arterial hypertension,
- Disabling heart or respiratory failure not allowing the completion of APA sessions,
- Active viral infection: hepatitis B, C and HIV,
- Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,
Lab values
- LVEF \<50%,
Other
- Any other type of lymphoma (T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma, etc.),
- Cerebral or meningeal damage related to hemopathy,
- Acquired or congenital motor or sensory deficit which does not allow the completion of APA sessions,
- Disabling osteo-articular or muscular pathology,
- Pregnancy or breastfeeding,
- Persons deprived of their liberty or under guardianship
- Patient who can't follow protocol for psychological, social, family or geographic reasons
Who the study is looking for
- Patient with diffuse large-cell B lymphoma regardless of the WHO 2016 classification subtype, or low-grade B lymphoma immediately transformed into high-grade B lymphoma (follicular lymphoma of the marginal zone, MALT, lymphocytic, lympho-plasma cells),
- Treatment naïve or having benefited from 2 cycles of chemotherapy (prephase or COP and cycle n ° 1 of RCHOP) if Performance Status\> 3 linked to hemopathy and reversible (≤ 2)
- Aged ≥ 65 years old,
- Eligible for treatment with RCHOP, regardless of the IPI score adjusted for age,
- Performance Status ≤ 2,
- Patient affiliated to a social security scheme,
- Patient who has given written consent before any specific procedure related to the study
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| Clinique Victor Hugo - Centre Jean Bernard Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| CHRU Nancy Coordinator of this site? Confirm its status | Nancy | France | Not yet recruiting |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Ch Perpignan Coordinator of this site? Confirm its status | Perpignan | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.