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Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

RecruitingPhase 3Ages 65 Years - anyAllWeprom
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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), 2. 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) 3. Aged ≥ 65 years old, 4. Eligible for treatment with RCHOP, regardless of the IPI score adjusted for age, 5. Performance Status ≤ 2, 6. Patient affiliated to a social security scheme, 7. Patient who has given written consent before any specific procedure related to the study Exclusion Criteria: 1. Any other type of lymphoma (T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma, etc.), 2. Cerebral or meningeal damage related to hemopathy, 3. Acquired or congenital motor or sensory deficit which does not allow the completion of APA sessions, 4. Uncontrolled arterial hypertension, 5. Disabling heart or respiratory failure not allowing the completion of APA sessions, 6. Disabling osteo-articular or muscular pathology, 7. LVEF \<50%, 8. Patient having received 3 or more cycles of 1st line chemotherapy, 9. Pregnancy or breastfeeding, 10. Active viral infection: hepatitis B, C and HIV, 11. Persons deprived of their liberty or under guardianship 12. 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, 13. Patient who can't follow protocol for psychological, social, family or geographic reasons
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What it tests

  • Adapted physical activity
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Where

5 sites
CHU Jean Minjoz
Besançon, France
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, France
CHRU Nancy
Nancy, France
Hôpital Privé du Confluent
Nantes, France
CH Perpignan
Perpignan, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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