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DLBCLPhase 2NCT04974216

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

A Phase 2 study testing Tafasitamab, Lenalidomide and Rituximab in people with DLBCL, run by The Lymphoma Academic Research Organisation at 20 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
DLBCL
What is being tested?
Tafasitamab, Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
20 sitesin 2 countries
Study dates
20 Dec 2021to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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)
  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

France15 sites

  • Centre Hospitalier D Avignon

    Avignon

  • Centre Hospitalier De La Cote Basque

    Bayonne

  • Besancon University Hospital Center

    Besançon, 25030

  • CHU de Bordeaux - Hôpital Haut Lévêque

    Bordeaux

  • Institut Bergonié - Bordeaux

    Bordeaux

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon

  • CH Saint Vincent de Paul

    Lille

  • CHRU de LILLE - Claude Huriez

    Lille

  • Chu de Limoges - Hopital Dupuytren

    Limoges

  • CHU de Nantes - Hôtel Dieu

    Nantes

  • APHP - Hôpital Saint Louis

    Paris

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270

  • CHU Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Belgium5 sites

  • Clinique Universitaire Saint LUC

    Brussels

  • Grand Hopital De Charleroi

    Charleroi, 6000

  • CHU Helora

    La Louvière, 7100

  • CHU de Liège

    Liège

  • CHRU Mont Godinne

    Yvoir

Other trials in Belgium

About this study

Official title: Phase II, Open-Label Study Evaluating Efficacy of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

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.

Read the detailed description

This study is an open-label, multi-centric, phase II study designed to 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.

After a screening phase, eligible patients will be enrolled and start the prephase treatment with vincristine and prednisone before day 1 of cycle 1 of the experimental drugs.

Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (R-miniCHOP) at Investigator's discretion and will remain in the study.

Conditions
DLBCL
Being tested
Tafasitamab, Lenalidomide, Rituximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafasitamabDrug

    Also called MOR208

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

  • LenalidomideDrug

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

  • RituximabDrug

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

Study groups in NCT04974216
Study groupRoleWhat they receive
R-Lena-TafaExperimental12 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
Receives: Drug: Tafasitamab; Drug: Lenalidomide; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR) by local assessment

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

    Measured: 3 months (3 cycles of 28 days)

Secondary outcomes (17)

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

    Measured: 13 months

  2. Number of SAE of patients who switched to RminiCHOP

    Measured: 7 months

  3. Progression free survival (PFS)

    Measured: 2 years

  4. Overall survival (OS)

    Measured: 2 years

  5. Overall Response Rate (ORR) by central assessment

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

    Measured: 3 months (3 cycles of 28 days)

  6. Complete Metabolic Response (CMR) by local assessment

    LOCAL ASSESSMENT

    Measured: 3 months (3 cycles of 28 days)

  7. Complete Metabolic Response (CMR) by central assessment

    CENTRAL ASSESSMENT

    Measured: 3 months (3 cycles of 28 days)

  8. Complete Metabolic Response (CMR) by local assessment

    LOCAL ASSESSMENT

    Measured: 6 months (6 cycles of 28 days)

  9. Complete Metabolic Response (CMR) by central assessment

    CENTRAL ASSESSMENT

    Measured: 6 months (6 cycles of 28 days)

  10. Complete Metabolic Response (CMR) by local assessment

    LOCAL ASSESSMENT

    Measured: 12 months (12 cycles of 28 days = end of treatment)

  11. Complete Metabolic Response (CMR) by central assessment

    CENTRAL ASSESSMENT

    Measured: 12 months (12 cycles of 28 days = end of treatment)

  12. Overall Response Rate (ORR) by local assessment

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

    Measured: 6 months (6 cycles of 28 days)

  13. Overall Response Rate (ORR) by central assessment

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

    Measured: 6 months (6 cycles of 28 days)

  14. Overall Response Rate (ORR) by local assessment

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

    Measured: 12 months (12 cycles of 28 days = end of treatment)

  15. Overall Response Rate (ORR) by central assessment

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

    Measured: 12 months (12 cycles of 28 days = end of treatment)

  16. Progression free survival (PFS) of patients who switched to RminiCHOP

    Measured: 3 years

  17. Overall survival (OS) of patients who switched to RminiCHOP

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start20 Dec 2021
  3. Primary completion15 Jul 2024
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974216
Sponsor's protocol ID
VERLen
Status last verified
Jun 2026
First submitted
13 Jul 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab, Lenalidomide and Rituximab in people with DLBCL, run by The Lymphoma Academic Research Organisation at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) by local assessment (time frame: 3 months (3 cycles of 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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