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

NCT04670029 | Recruiting Phase 3

• 2 other identifiers: WP-2020-032019-A02248-49
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• To detect an absolute difference of 15% in event-free survival between the 2 groups

  Event-free survival will be defined as the time between the date of inclusion and the date of the event or the date of the latest news if the patient is censored.

  5 years

Secondary Outcomes (16)

• The compliance with the 72 sessions of APA

  6 months

• The overall physical activity load per patient and per session

  6 months

• The overall survival

  5 years

• The progression free survival

  5 years

• The progression-free survival after relapse and resumption of therapy

  5 years

Study Arms (2)

Standard

NO INTERVENTION

APA

EXPERIMENTAL

* During the first 3 cures, 3 APA sessions will be offered per week: * 2 sessions of anaerobic type of 1 hour with muscle strengthening, stretching, flexibility and balance, supervised in the room, * 1 aerobic type exercise session of 1.5 hours (Nordic walking: outdoors) or a 3rd indoor session if not possible, * \+ home exercise book if the patient so wishes with record the time in minutes per session and the intensity felt and the modalities of the exercises carried out. * During the 5 remaining cycles, 3 APA sessions will be offered per week: * 1 session of 1 hour in an anaerobic exercise room (muscle strengthening, stretching, flexibility, balance) supervised, * 1 session of anaerobic exercise per week in autonomy at home (with exercise book), * 1 or more session per week of one hour of walking or cycling independently at home (aerobic effort) with declaration in the logbook of the intensity of exertion felt and the time in minutes per session.

Other: Adapted physical activity

Interventions

Adapted physical activity OTHER

APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)

APA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weprom: lead

Study Sites (5)

CHU Jean Minjoz

Besançon, 25030, France

NOT YET RECRUITING

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, 72000, France

RECRUITING

CHRU Nancy

Nancy, 54500, France

NOT YET RECRUITING

Hôpital Privé du Confluent

Nantes, 44277, France

RECRUITING

CH Perpignan

Perpignan, 66046, France

RECRUITING

Related Publications (1)

• Dubu J, Boyas S, Roland V, Landry S, Septans AL, Balavoine M, Bourgeois H, Pointreau Y, Denis F, Letellier C, Le Du K. Physical Activity Program for the Survival of Elderly Patients With Lymphoma: Study Protocol for Randomized Phase 3 Trial. JMIR Res Protoc. 2022 Nov 25;11(11):e40969. doi: 10.2196/40969.

  PMID: 36427234 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katell LE DÛ, MD

  Clinique Victor Hugo/Centre Jean Bernard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali BALAVOINE

CONTACT

0241682940; m.balavoine@weprom.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: September 8, 2021
• Primary Completion: August 1, 2025
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)