Actively Recruiting

Phase 3
Age: 65Years +
All Genders
NCT04670029

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

Led by Weprom · Updated on 2021-10-08

186

Participants Needed

5

Research Sites

386 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with diffuse large-cell B lymphoma or low-grade B lymphoma immediately transformed into high-grade B lymphoma
  • Treatment-nafve or having received up to 2 cycles of chemotherapy if reversible performance status >3
  • Aged 65 years or older
  • Eligible for RCHOP chemotherapy regardless of age-adjusted IPI score
  • Performance status of 2 or less
  • Affiliated to a social security scheme
  • Provided written informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Any other lymphoma type (e.g., T lymphoma, Burkitt's lymphoma, non-transformed low-grade B lymphoma)
  • Brain or meningeal involvement related to lymphoma
  • Motor or sensory deficits preventing participation in physical activity sessions
  • Uncontrolled high blood pressure
  • Disabling heart or respiratory failure
  • Disabling bone, joint, or muscle conditions
  • Left ventricular ejection fraction below 50%
  • Received 3 or more cycles of first-line chemotherapy
  • Pregnancy or breastfeeding
  • Active hepatitis B, C, or HIV infection
  • Detained persons or under legal guardianship
  • Dementia, mental impairment, or psychiatric illness affecting consent or compliance
  • Inability to follow the protocol due to psychological, social, family, or geographic reasons

AI-Screening

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Trial Site Locations

Total: 5 locations

1

CHU Jean Minjoz

Besançon, France, 25030

Not Yet Recruiting

2

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, France, 72000

Actively Recruiting

3

CHRU Nancy

Nancy, France, 54500

Not Yet Recruiting

4

Hôpital Privé du Confluent

Nantes, France, 44277

Actively Recruiting

5

CH Perpignan

Perpignan, France, 66046

Actively Recruiting

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Research Team

M

Magali BALAVOINE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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