Description:
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. Annual
incidence increases with age and achieves more than 30 per 100 000 patients 65 years old or
over.
Despite high response rates with conventional regimen as R-CHOP (Rituximab, Cyclophosphamide,
Doxorubicin, Vincristine and Prednisone), 30% to 40% of patients develop a relapse or a
refractory disease, with a poor prognosis. There is no standard chemotherapy in second line
for elderly patients, which are not eligible to receive a salvage treatment by high-dose
therapy followed by autologous stem cell transplantation. The median
progression-free-survival (PFS) is less than one year with the most commonly used regimens
including R-Gemcitabine-Oxaliplatin (R-GEMOX) and R-Bendamustine. One the other side,
Rituximab plus Lenalidomide, an immunomodulatory agent, is an active new therapeutic
approach, with an efficacy proved in a phase II trial with a patients with a prolonged
disease-free-survival of 32 months for responders in patients with a median age of 74 years
old. This combination is also efficient in the ABC phenotype DLBCL which is more common in
elderly patients.
For elderly patients, a management of the geriatric impairment together with lymphoma is
required. Indeed, a comprehensive geriatric assessment detects frailty and vulnerability in
elderly with a lymphoma and predicts severe treatment related toxicity, treatment settings
and progression free survival. Moreover, geriatric intervention improved outcome, autonomy
and quality of life. Functional status, assessed by Activities of patients Daily Living (ADL)
is an independent predictive factor for feasibility of chemotherapy in elderly patients with
cancer. The mini Data Set of DIALOG group is a new simplified geriatric assessment for
oncologist.
Title
- Brief Title: Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
- Official Title: Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
PI2018_843_0051
- NCT ID:
NCT04113226
Conditions
- Chemotherapy
- Diffuse Large B-Cell Lymphoma (DLBCL), Nos
- Elderly
Interventions
| Drug | Synonyms | Arms |
|---|
| Rituximab | | classical rituximab-based chemotherapy |
| Lenalidomide 20 MG | | rituximab plus lenalidomide |
Purpose
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. Annual
incidence increases with age and achieves more than 30 per 100 000 patients 65 years old or
over.
Despite high response rates with conventional regimen as R-CHOP (Rituximab, Cyclophosphamide,
Doxorubicin, Vincristine and Prednisone), 30% to 40% of patients develop a relapse or a
refractory disease, with a poor prognosis. There is no standard chemotherapy in second line
for elderly patients, which are not eligible to receive a salvage treatment by high-dose
therapy followed by autologous stem cell transplantation. The median
progression-free-survival (PFS) is less than one year with the most commonly used regimens
including R-Gemcitabine-Oxaliplatin (R-GEMOX) and R-Bendamustine. One the other side,
Rituximab plus Lenalidomide, an immunomodulatory agent, is an active new therapeutic
approach, with an efficacy proved in a phase II trial with a patients with a prolonged
disease-free-survival of 32 months for responders in patients with a median age of 74 years
old. This combination is also efficient in the ABC phenotype DLBCL which is more common in
elderly patients.
For elderly patients, a management of the geriatric impairment together with lymphoma is
required. Indeed, a comprehensive geriatric assessment detects frailty and vulnerability in
elderly with a lymphoma and predicts severe treatment related toxicity, treatment settings
and progression free survival. Moreover, geriatric intervention improved outcome, autonomy
and quality of life. Functional status, assessed by Activities of patients Daily Living (ADL)
is an independent predictive factor for feasibility of chemotherapy in elderly patients with
cancer. The mini Data Set of DIALOG group is a new simplified geriatric assessment for
oncologist.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| classical rituximab-based chemotherapy | Active Comparator | Rituximab-based physician's choice chemotherapy | |
| rituximab plus lenalidomide | Experimental | Four 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression. | - Rituximab
- Lenalidomide 20 MG
|
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 75 years old
- Histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification
2008) including all clinical subtypes (primary mediastinal, intravascular, etc...),
with all aaIPI. May also be included : transformed DLBCL from low grade lymphoma
(Follicular, other...) and DLBCL associated with some small cell Infiltration in bone
marrow or lymph node or CD20+ B-cell lymphoma, with intermediate features between
DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin
lymphoma or CD20+ Follicular lymphoma grade 3B or CD20+ Aggressive B-cell lymphoma
unclassifiable
- Relapse ≥ 6 months
- ADL ≥ 2
- Negative HIV, HBV (anti-HBc negativity) and HCV serologies test within 4 weeks before
inclusion
- Patient able to give his consent and having signed a written informed consent
- Registration in a national health-care system
Exclusion Criteria:
- Central nervous system or meningeal involvement by lymphoma
- Poor renal function (creatinine clearance < 30 ml/min, according to MDRD formula)
- Poor hepatic function (total bilirubin level>30mmol/l, transaminases >2.5 maximum
normal level) unless these abnormalities are related to the lymphoma
- Neuropathy grade > 1
- Poor bone marrow reserve as defined by neutrophils<1.5 G/l or platelets<100 G/l,
unless related to bone marrow infiltration
- Other concomitant or previous malignancy, except adequately treated in situ carcinoma
of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in
complete remission for <5 years
- Other serious and uncontrolled non-malignant disease.
- Insufficient proficiency of the French language and disability to complete a
questionnaire
- Patient under guardianship
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 75 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression of free survival at 6 months in elderly patients treated with Rituximab plus Lenalidomide or Rituximab plus chemotherapy. |
| Time Frame: | at 6 months |
| Safety Issue: | |
| Description: | Progression of free survival at 6 months with maintain autonomy without loss of 0.5 point of ADL in elderly patients 75 years old and over with relapsed diffuse large B-cell lymphoma treated with Rituximab plus Lenalidomide or Rituximab plus investigator's choice . |
Secondary Outcome Measures
| Measure: | Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
| Time Frame: | at 6 months |
| Safety Issue: | |
| Description: | Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
| Measure: | Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
| Time Frame: | at 6 months |
| Safety Issue: | |
| Description: | Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Centre Hospitalier Universitaire, Amiens |
Trial Keywords
- chemotherapy
- Diffuse large B cell lymphoma (DLBCL)
- Relapse
- activities of patients daily living
- Elderly
- Lenalidomide
Last Updated
July 30, 2021
