Impact of physical activity on survival in patients with diffuse large B cell lymphoma

Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

This study tests if a special exercise program can help older patients with diffuse large B cell lymphoma live longer and have fewer relapses while they are getting their first treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Weprom (other)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Besançon and 4 other locations)
• Trial ID: NCT04670029 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of an adapted physical activity program on event-free survival in patients diagnosed with diffuse large B cell lymphoma who are receiving first-line treatment. The study focuses on older patients, particularly those aged 65 and above, who may have additional health challenges such as sarcopenia. By incorporating physical activity into their treatment regimen, the trial aims to assess whether this approach can improve overall outcomes and reduce the risk of relapse. Participants will be monitored for their response to treatment and any changes in their health status throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 and older with a diagnosis of diffuse large B cell lymphoma who are eligible for RCHOP treatment.

Not a fit: Patients with other types of lymphoma or significant motor or sensory deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance survival rates and quality of life for older patients with diffuse large B cell lymphoma.

How similar studies have performed: While the specific combination of physical activity and lymphoma treatment is novel, similar approaches in other cancer types have shown promising results.

Eligibility criteria

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

Where this trial is running

Besançon and 4 other locations

• CHU Jean Minjoz — Besançon, France (NOT_YET_RECRUITING)
• Clinique Victor Hugo / Centre Jean Bernard — Le Mans, France (RECRUITING)
• CHRU Nancy — Nancy, France (NOT_YET_RECRUITING)
• Hôpital Privé du Confluent — Nantes, France (RECRUITING)
• CH Perpignan — Perpignan, France (RECRUITING)

Study contacts

• Principal investigator: Katell LE DÛ, MD — Clinique Victor Hugo/Centre Jean Bernard
• Study coordinator: Magali BALAVOINE

Conditions: Diffuse Large B Cell Lymphoma