Study to determine the efficacy of Tafasitamab and lenalidomide administered in association with rituximab in frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or older .
- Conditions
- Frontline DLBCLMedDRA version: 21.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004977-38-FR
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 71
Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all aaIPI. May also be enrolled the following malignancies:
•De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow or lymph node.
•High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
•High-grade B-cell lymphoma, NOS
•Follicular lymphoma grade 3B
OR
Previously untreated high-grade B-cell lymphoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71
1.Any other histological type of lymphoma, Burkitt included
2.Any history of treated or non-treated Small-B cell lymphoma prior Aggressive B Cell lymphoma diagnosis
3.Central nervous system or meningeal involvement by lymphoma
4.Any serious active disease (according to the investigator’s decision)
5.Poor renal function (calculated MDRD or Cockcroft-Gault creatinine clearance < 30 ml/min)
6.Poor hepatic function (total bilirubin level >30 µmol/l, transaminases >2.5 upper normal limits) unless these abnormalities are related to lymphoma
7.Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration by lymphoma cells (Bone Marrow Aspiration will be mandatory in case of severe cytopenias prior inclusion)
8.Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score =7, and a prostate specific antigen (PSA) =10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
9.Treatment with any investigational drug within 30 days prior to prephase treatment and during the study
10.Known HIV, active HCV infection or positive HBV test within 4 weeks before enrollment (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
11.Prior treatment with anti-CD20/anti-CD19 monoclonal antibody or alemtuzumab within 3 months prior to prephase treatment
12.Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide
13.Contra-indication to highly dosed glucocorticoid (60 mg/m2/d)
14.Neuropathy = Grade 2 or painful
15.Patient deprived of his/her liberty by a judicial or administrative decision
16.Adult patient under legal protection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method