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Clinical Trials in Belgium / NCT04974216
Active, not recruiting Phase 2

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

NCT04974216 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 2
Started
2021-12-20
Last updated
2026-06-04

Condition(s) studied

DLBCL

Investigational drug(s) / intervention(s)

Tafasitamab →Lenalidomide →Rituximab →

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
80 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 2.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) Exclusion Criteria: 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 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 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) 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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Clinique Universitaire Saint LUC Brussels Belgium
Grand Hopital De Charleroi Charleroi Belgium
CHU Helora La Louvière Belgium
CHU de Liège Liège Belgium
CHRU Mont Godinne Yvoir Belgium
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier De La Cote Basque Bayonne France
Besancon University Hospital Center Besançon France
CHU de Bordeaux - Hôpital Haut Lévêque Bordeaux France
Institut Bergonié - Bordeaux Bordeaux France
Centre Hospitalier Sud Francilien Corbeil-Essonnes France
Centre Hospitalier Departemental Vendee La Roche-sur-Yon France
CH Saint Vincent de Paul Lille France
CHRU de LILLE - Claude Huriez Lille France
Chu de Limoges - Hopital Dupuytren Limoges France
CHU de Nantes - Hôtel Dieu Nantes France
APHP - Hôpital Saint Louis Paris France
Centre Henri Becquerel Rouen France
Institut de Cancérologie de la Loire Lucien Neuwirth Saint-Priest-en-Jarez France
CHU Brabois Vandœuvre-lès-Nancy France

On this site

📄 Revlimid (lenalidomide) drug profile → 📄 Rituxan (rituximab) drug profile →

More The Lymphoma Academic Research Organisation trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04974216 on ClinicalTrials.gov ↗ ← All trials in Belgium