New cocktail aims to tame aggressive lymphoma in the very elderly
NCT ID NCT04974216
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a combination of three drugs—tafasitamab, lenalidomide, and rituximab—in people aged 80 and older with untreated diffuse large B-cell lymphoma (DLBCL). The goal is to see if this gentler, chemotherapy-free regimen can shrink or eliminate tumors after three cycles of treatment. The study enrolled 71 participants and is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tafasitamab, lenalidomide, and rituximab
- What this could lead to
- If successful, this combination could offer a gentler, effective treatment option for elderly patients with diffuse large B-cell lymphoma who cannot tolerate standard chemotherapy.
- What could go wrong
- This is a small, early-phase trial (71 patients) with no comparison group. The drugs may cause serious side effects, and the results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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71 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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80 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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APHP - Hôpital Saint Louis
Paris, France
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Besancon University Hospital Center
Besançon, 25030, France
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CH Saint Vincent de Paul
Lille, France
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CHRU Mont Godinne
Yvoir, Belgium
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CHRU de LILLE - Claude Huriez
Lille, France
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CHU Brabois
Vandœuvre-lès-Nancy, France
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CHU Helora
La Louvière, 7100, Belgium
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CHU de Bordeaux - Hôpital Haut Lévêque
Bordeaux, France
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CHU de Liège
Liège, Belgium
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CHU de Nantes - Hôtel Dieu
Nantes, France
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Centre Henri Becquerel
Rouen, France
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Centre Hospitalier D Avignon
Avignon, France
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Centre Hospitalier De La Cote Basque
Bayonne, France
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Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, France
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Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
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Chu de Limoges - Hopital Dupuytren
Limoges, France
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Clinique Universitaire Saint LUC
Brussels, Belgium
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Grand Hopital De Charleroi
Charleroi, 6000, Belgium
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Institut Bergonié - Bordeaux
Bordeaux, France
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Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, 42270, France
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