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.
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
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,
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- 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.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
CHU Jean Minjoz
Besançon, 25030
Adrien CHAUCHET, MD, 0381669024 ext. 0033, achauchet@chu-besancon.fr
Adrien CHAUCHET
- 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
- Not yet recruiting
CHRU Nancy
Nancy, 54500
Pierre FEUGIER, MD, 0383153282 ext. 0033, p.feugier@chru-nancy.fr
Pierre FEUGIER, MD
- 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
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.
- Conditions
- Diffuse Large B Cell Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Not described |
| 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. Receives: Other: Adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The compliance with the 72 sessions of APA
Number of sessions performed per patient per part of the program
Measured: 6 months
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
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
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
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
The complete and partial response rates
according to Lugano criteria
Measured: 1 year
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
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
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
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
The rate of second cancers
Number of patients who presented with a second cancer during the study
Measured: 5 years
The rate of cardiovascular events
Number of patients with a cardiovascular event
Measured: 5 years
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
The fatigue of patient
Change from baseline of Multidimensional fatigue inventory score (higher score means worse outcome)
Measured: 5 years
The depression of patient
Change from baseline of Geriatric depression scale (higher score means worse outcome)
Measured: 5 years
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.
- First posted17 Dec 2020
- Study start8 Sep 2021
- Primary completionAug 2025 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katell LE DÛ, MD, Principal investigator, Clinique Victor Hugo/Centre Jean Bernard
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