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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Victor Hugo / Centre Jean Bernard
  Le Mans, France Recruiting
• Hôpital Privé du Confluent
  Nantes, France Recruiting
• CH Perpignan
  Perpignan, France Recruiting
• CHU Jean Minjoz
  Besançon, France Not yet recruiting
• CHRU Nancy
  Nancy, France Not yet recruiting

Study contacts

• Principal investigator: Katell LE DÛ, MD — Clinique Victor Hugo/Centre Jean Bernard
• Study coordinator: Magali BALAVOINE
• Email: m.balavoine@weprom.fr
• Phone: 0241682940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.