AzTrials
AzTrials

Diffuse Large B Cell LymphomaPhase 3PHARAOMNCT04670029

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

A Phase 3 study testing Adapted physical activity in people with Diffuse Large B Cell Lymphoma, run by Weprom at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Adapted physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
5 sitesFrance
Study dates
8 Sep 2021to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Magali BALAVOINE contact

0241682940 ext. 0033

m.balavoine@weprom.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • CHU Jean Minjoz

    Besançon, 25030

    Adrien CHAUCHET, MD, 0381669024 ext. 0033, achauchet@chu-besancon.fr

    Adrien CHAUCHET

    Not yet recruiting

  • Clinique Victor Hugo / Centre Jean Bernard

    Le Mans, 72000

    Katell LE DÛ, MD, 0243391300 ext. 0033, k.ledu@cjb72.org

    Katell LE DÛ, MD

    Recruiting

  • CHRU Nancy

    Nancy, 54500

    Pierre FEUGIER, MD, 0383153282 ext. 0033, p.feugier@chru-nancy.fr

    Pierre FEUGIER, MD

    Not yet recruiting

  • Hôpital Privé du Confluent

    Nantes, 44277

    Sophie LEBOUVIER-SADOT, MD, 0228272118 ext. 0033, sophie.sadot.lebouvier@groupeconfluent.fr

    Sophie LEBOUVIER-SADOT, MD

    Recruiting

  • CH Perpignan

    Perpignan, 66046

    Virginie ROLAND, MD, 0468618907 ext. 0033, virginie.roland@ch-perpignan.fr

    Virginie ROLAND, MD

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Being tested
Adapted physical activity
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted physical activityOther

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

Study groups in NCT04670029
Study groupRoleWhat they receive
StandardNo interventionNot described
APAExperimental* 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.
Receives: Other: Adapted physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (16)

  1. The compliance with the 72 sessions of APA

    Number of sessions performed per patient per part of the program

    Measured: 6 months

  2. The overall physical activity load per patient and per session

    Evaluated according to the Foster method (duration of the session in minutes x perceived effort according to the modified Borg scale)

    Measured: 6 months

  3. The overall survival

    Time between the date of inclusion and the date of death if the patient is deceased or the date of the latest news if the patient is censored

    Measured: 5 years

  4. The progression free survival

    time between the inclusion date and the date of the first examination showing Progression of the disease or the date of death if the patient is deceased or the date of the latest news if the patient is censored

    Measured: 5 years

  5. The progression-free survival after relapse and resumption of therapy

    Time between the date of the start of re-treatment and the date of the first examination showing progression of the disease or the date of death if the patient has died or the date of the latest news if the patient is censored,

    Measured: 5 years

  6. The complete and partial response rates

    according to Lugano criteria

    Measured: 1 year

  7. The prevalence of complications

    Number of patients who presented complication in the numerator and the number of patients followed in the denominator

    Measured: 6 months

  8. The incidence of sarcopenia during follow-up

    by CT scan during follow-up will be evaluated by the number of patients with sarcopenia diagnosed during follow-up in the numerator and the number of patients followed in the denominator

    Measured: 2 years

  9. The prevalence of nutritional disorders at diagnosis and at the end of treatment

    The number of patients with a disorder of nutritional status in the numerator and the number of patients followed in the denominator,

    Measured: 6 months

  10. The rate of endocrinopathies

    Number of patients with endocrinopathy between the inclusion date and the study discharge date in the numerator and the number of patients followed in the denominator

    Measured: 6 months

  11. The rate of second cancers

    Number of patients who presented with a second cancer during the study

    Measured: 5 years

  12. The rate of cardiovascular events

    Number of patients with a cardiovascular event

    Measured: 5 years

  13. The quality of life of patients

    Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)

    Measured: 5 years

  14. The fatigue of patient

    Change from baseline of Multidimensional fatigue inventory score (higher score means worse outcome)

    Measured: 5 years

  15. The depression of patient

    Change from baseline of Geriatric depression scale (higher score means worse outcome)

    Measured: 5 years

  16. The cost of hospitalizations

    Hospitalizations will be quote (economic data) by medical information department of center

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start8 Sep 2021
  3. Primary completionAug 2025 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670029
Sponsor's protocol ID
WP-2020-03
Other IDs
2019-A02248-49
Acronym
PHARAOM
Status last verified
Apr 2021
First submitted
9 Dec 2020
Last updated
8 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36427234

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adapted physical activity in people with Diffuse Large B Cell Lymphoma, run by Weprom at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magali BALAVOINE (0241682940 ext. 0033, m.balavoine@weprom.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To detect an absolute difference of 15% in event-free survival between the 2 groups (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in