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

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ClinicalTrials.gov Identifier: NCT04974216
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Study Description
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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.

Condition or disease Intervention/treatment Phase
DLBCL Drug: Tafasitamab Drug: Lenalidomide Drug: Rituximab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: R-Lena-Tafa

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
Administration : IV at 12mg/Kg C1 to C3: D1, D8, D15, D22 C4 to C6: D1, D15 C7 to C12: D1
Other Name: MOR208

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    LOCAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAE) of patients treated with lenalidomide and tafasitamab [ Time Frame: 13 months ]
  2. Number of SAE of patients who switched to RminiCHOP [ Time Frame: 7 months ]
  3. Progression free survival (PFS) [ Time Frame: 2 years ]
  4. Overall survival (OS) [ Time Frame: 2 years ]
  5. Overall Response Rate (ORR) by central assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    CENTRAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  6. Complete Metabolic Response (CMR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    LOCAL ASSESSMENT

  7. Complete Metabolic Response (CMR) by central assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    CENTRAL ASSESSMENT

  8. Complete Metabolic Response (CMR) by local assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    LOCAL ASSESSMENT

  9. Complete Metabolic Response (CMR) by central assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    CENTRAL ASSESSMENT

  10. Complete Metabolic Response (CMR) by local assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    LOCAL ASSESSMENT

  11. Complete Metabolic Response (CMR) by central assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    CENTRAL ASSESSMENT

  12. Overall Response Rate (ORR) by local assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    LOCAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  13. Overall Response Rate (ORR) by central assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    CENTRAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  14. Overall Response Rate (ORR) by local assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    LOCAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  15. Overall Response Rate (ORR) by central assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    CENTRAL ASSESSMENT : Complete Metabolic Response + Partial Metabolic Response based according to Lugano Response Criteria

  16. Progression free survival (PFS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]
  17. Overall survival (OS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974216


Locations
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Belgium
Clinique Universitaire Saint LUC Recruiting
Brussels, Belgium
Contact: Sarah Bailly, MD    +32 (0)27 64 18 09    sarah.bailly@uclouvain.be   
CHU de Liège Recruiting
Liège, Belgium
Contact: Christophe BONNET, MD    +32 (0) 43 66 72 01    cbonnet@uliege.be   
CHRU Mont Godinne Recruiting
Yvoir, Belgium
Contact: Julien DEPAUS, MD    +32 (0) 81 42 38 42    julien.depaus@uclouvain.be   
France
CHU de Bordeaux - Hôpital Haut Lévêque Recruiting
Bordeaux, France
Contact: François-Xavier GROS, MD    +33 (0)5 57 65 60 18    francois-xavier.gros@chu-bordeaux.fr   
Institut Bergonié - Bordeaux Recruiting
Bordeaux, France
Contact: Anna SCHMITT, MD    +33 (0)5 56 33 04 12    a.schmitt@bordeaux.unicancer.fr   
CH Saint Vincent de Paul Recruiting
Lille, France
Contact: AMORIM Sandy, MD    00 33 3 20 87 45 32    amorim.sandy@ghicl.net   
CHRU de LILLE - Claude Huriez Recruiting
Lille, France
Contact: Franck MORSHHAUSER, Pr    +33 (0)3 20 44 57 13    franck.morschhauser@chru-lille.fr   
Chu de Limoges - Hopital Dupuytren Recruiting
Limoges, France
Contact: Julie ABRAHAM, MD    +33 (0)5 55 05 66 51    julie.abraham@chu-limoges.fr   
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France
Contact: benoit TESSOULIN, Pr    +33 (0)2 40 08 32 89    benoit.tessoulin@chu-nantes.fr   
Centre Antoine Lacassagne Recruiting
Nice, France
Contact: Fréderic PEYRADE, Pr    +33 (0)4 92 03 10 22    frederic.peyrade@nice.unicancer.fr   
APHP - Hôpital Saint Louis Recruiting
Paris, France
Contact: loic Renaud, Dr    +33 (0)6 70 65 69 93    renaud.loic@aphp.fr   
Centre Henri Becquerel Recruiting
Rouen, France
Contact: Fabrice JARDIN, Pr    +33 (0)2 32 08 24 65    fabrice.jardin@chb.unicancer.fr   
Centre René Huguenin - Institut Curie Recruiting
Saint-Cloud, France
Contact: Sandra MALAK, MD    +33 (0)1 47 11 23 83    sandra.malak@curie.fr   
Institut de Cancérologie de la Loire Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Ludovic FOUILLET, MD    +33(0)4 77 91 74 18    ludovic.fouillet@icloire.fr   
CHU Brabois Recruiting
Vandoeuvre les Nancy, France
Contact: Pierre FEUGIER, Pr    +33 (0)3 83 15 32 57    p.feugier@chru-nancy.fr   
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
More Information
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT04974216    
Other Study ID Numbers: VERLen
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
 Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors