Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

NCT04974216 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: VERLen
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 15

Brief Summary

This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

Conditions

DLBCL

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) by local assessment

  LOCAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  3 months (3 cycles of 28 days)

Secondary Outcomes (17)

• Number of Serious Adverse Events (SAE) of patients treated with lenalidomide and tafasitamab

  13 months

• Number of SAE of patients who switched to RminiCHOP

  7 months

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Overall Response Rate (ORR) by central assessment

  3 months (3 cycles of 28 days)

Study Arms (1)

R-Lena-Tafa

EXPERIMENTAL

12 cycles of 28 days. From C1 to C6 : rituximab + tafasitamab + lenalidomide and from C7 to C12: tafasitamab and lenalidomide Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (rituximab + cyclophosphamide + adriamycine + vincristine + prednisone R-miniCHOP) at Investigator's discretion according to local practices

Drug: Tafasitamab; Drug: Lenalidomide; Drug: Rituximab

Interventions

Tafasitamab DRUG

Administration : IV at 12mg/Kg C1 to C3: D1, D8, D15, D22 C4 to C6: D1, D15 C7 to C12: D1

Also known as: MOR208

R-Lena-Tafa

Lenalidomide DRUG

Oral administration: hard capsule C1 to C6: 20mg/day C7 to C12: 15mg/day

R-Lena-Tafa

Rituximab DRUG

Administration: IV at 375mg/m2 C1 to C6: D1

R-Lena-Tafa

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all International Prognostic Index (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, Not Otherwise Specified (NOS)
• Follicular lymphoma grade 3B 3.Positron-Emission Tomography (PET)-positive disease 4.Previously untreated high-grade B-cell lymphoma 5.Aged ≥ 80 years old at the time of signing the informed consent form (ICF) 6.Ann Arbor stage I, II, III or IV 7.Eastern Cooperative Oncology Group (ECO)G performance status ≤ 2 8.With a minimum life expectancy of 3 months 9.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 10. Patients should be able to receive R-miniCHOP regimen (left ventricular ejection fraction \> 50% and good general condition, according to investigator's judgment) 11. Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin or low molecular weight heparin) 12. Patient covered by any social security system (France)

You may not qualify if:

• Any other histological type of lymphoma, Burkitt included
• 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
• 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
• Known HIV, active Hepatitis C Virus (HCV) infection or positive Hepatitis B Virus (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

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (15)

Clinique Universitaire Saint LUC

Brussels, Belgium

Location

CHU de Liège

Liège, Belgium

Location

CHRU Mont Godinne

Yvoir, Belgium

Location

CHU de Bordeaux - Hôpital Haut Lévêque

Bordeaux, France

Location

Institut Bergonié - Bordeaux

Bordeaux, France

Location

CH Saint Vincent de Paul

Lille, France

Location

CHRU de LILLE - Claude Huriez

Lille, France

Location

Chu de Limoges - Hopital Dupuytren

Limoges, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

APHP - Hôpital Saint Louis

Paris, France

Location

Centre Henri Becquerel

Rouen, France

Location

Centre René Huguenin - Institut Curie

Saint-Cloud, France

Location

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Interventions

tafasitamab; Lenalidomide; Rituximab

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 23, 2021
• Study Start: December 20, 2021
• Primary Completion: July 15, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (12)