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

Phase 2

Active, not recruiting

Conditions: Diffuse Large B-Cell Lymphoma

Registration Number: 2023-507286-25-00

Lead Sponsor: LYSARC

Brief Summary: Evaluate the efficacy of tafasitamab (anti-CD19 antibody) and lenalidomide associated with rituximab (R-Tafa-Len) in elderly patients as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment or at permanent treatment discontinuation, whichever occurs first.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.		ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.

Secondary Outcome Measures

Name	Time	Method
Central review of PET-CT according to Lugano Response Criteria		Central review of PET-CT according to Lugano Response Criteria
Complete Metabolic response (CMR) rates based on investigator disease assessment and central assessment		Complete Metabolic response (CMR) rates based on investigator disease assessment and central assessment
Overall Survival (OS)		Overall Survival (OS)
Quality of Life (QoL)		Quality of Life (QoL)
Progression Free Survival (PFS)		Progression Free Survival (PFS)
Assess safety of lenalidomide and tafasitamab in the context of patients treated by rituximab		Assess safety of lenalidomide and tafasitamab in the context of patients treated by rituximab

Trial Locations

Locations (20): Cliniques Universitaires Saint-Luc
🇧🇪
Sint-Lambrechts-Woluwe, Belgium
Grand Hopital De Charleroi
🇧🇪
Charleroi, Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
🇧🇪
Yvoir, Belgium
CHU Helora
🇧🇪
La Louviere, Belgium
CHU De Liege
🇧🇪
Liege, Belgium
Besancon University Hospital Center
🇫🇷
Besancon Cedex, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷
Saint-Priest-En-Jarez, France
Centre Hospitalier Universitaire De Nantes
🇫🇷
Nantes, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille Cedex, France
Institut Bergonie
🇫🇷
Bordeaux, France
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Cliniques Universitaires Saint-Luc
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Sarah BAILLY
Site contact
027641809
sarah.bailly@uclouvain.be