VERLEN - Phase II, Open-Label Study evaluating efficacy of Lenalidomide and Tafasitamab combination associated to Rituximab in frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or older
- Conditions
- Diffuse Large B-Cell LymphomaMedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-507286-25-00
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
Patient must understand and voluntarily sign an Informed Consent Form prior to any study-specific assessments/procedures being conducted, Patients should be able to receive R-miniCHOP regimen (left ventricular ejection fraction > 50% and good general condition, according to investigator’s judgment), Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin or low molecular weight heparin), Patient covered by any social security system (France), Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all IPI. 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, Positron-Emission Tomography (PET)-positive disease, Previously untreated high-grade B-cell lymphoma, Aged = 80 years old at the time of signing the informed consent form (ICF), Ann Arbor stage I, II, III or IV, ECOG performance status = 2, With a minimum life expectancy of 3 months, Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 4 months following study drug discontinuation, even if they have undergone a successful vasectomy
Any other histological type of lymphoma, Burkitt included, 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), Prior treatment with anti-CD20/anti-CD19 monoclonal antibody or alemtuzumab within 3 months prior to prephase treatment, Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide, Contra-indication to highly dosed glucocorticoid (60 mg/m2/d), Neuropathy = Grade 2 or painful, Patient deprived of his/her liberty by a judicial or administrative decision, Adult patient under legal protection, Any history of treated or non-treated Small-B cell lymphoma prior Aggressive B Cell lymphoma diagnosis, Central nervous system or meningeal involvement by lymphoma, Any serious active disease (according to the investigator’s decision), Poor renal function (calculated Cockcroft-Gault creatinine clearance < 30 ml/min), Poor hepatic function (total bilirubin level >30 µmol/l, transaminases >2.5 upper normal limits) unless these abnormalities are related to lymphoma, Poor bone marrow reserve as defined by neutrophils <1G/L or platelets <100G/L, even if there is bone marrow infiltration by lymphoma. A Bone Marrow Aspiration will be mandatory prior inclusion for patients with neutrophils <1.5 G/L or Hemoglobin <9g/dL in order to exclude patients with concomitant myelodysplasia., 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, Treatment with any investigational drug within 30 days prior to prephase treatment and during the study
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