Status:
RECRUITING
Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
Lead Sponsor:
Weprom
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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,
- Uncontrolled arterial hypertension,
- Disabling heart or respiratory failure not allowing the completion of APA sessions,
- Disabling osteo-articular or muscular pathology,
- LVEF \<50%,
- Patient having received 3 or more cycles of 1st line chemotherapy,
- Pregnancy or breastfeeding,
- Active viral infection: hepatitis B, C and HIV,
- Persons deprived of their liberty or under guardianship
- 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,
- Patient who can't follow protocol for psychological, social, family or geographic reasons
Key Trial Info
Start Date :
September 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT04670029
Start Date
September 8 2021
End Date
February 1 2029
Last Update
October 8 2021
Active Locations (5)
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1
CHU Jean Minjoz
Besançon, France, 25030
2
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, France, 72000
3
CHRU Nancy
Nancy, France, 54500
4
Hôpital Privé du Confluent
Nantes, France, 44277