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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

Tracking Information
First Submitted Date  ICMJE July 13, 2021
First Posted Date  ICMJE July 23, 2021
Last Update Posted Date March 4, 2022
Actual Study Start Date  ICMJE December 20, 2021
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
  • Number of Serious Adverse Events (SAE) of patients treated with lenalidomide and tafasitamab [ Time Frame: 13 months ]
  • Number of SAE of patients who switched to RminiCHOP [ Time Frame: 7 months ]
  • Progression free survival (PFS) [ Time Frame: 2 years ]
  • Overall survival (OS) [ Time Frame: 2 years ]
  • 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
  • Complete Metabolic Response (CMR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    LOCAL ASSESSMENT
  • Complete Metabolic Response (CMR) by central assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
    CENTRAL ASSESSMENT
  • Complete Metabolic Response (CMR) by local assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    LOCAL ASSESSMENT
  • Complete Metabolic Response (CMR) by central assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
    CENTRAL ASSESSMENT
  • Complete Metabolic Response (CMR) by local assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    LOCAL ASSESSMENT
  • Complete Metabolic Response (CMR) by central assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
    CENTRAL ASSESSMENT
  • 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
  • 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
  • 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
  • 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
  • Progression free survival (PFS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]
  • Overall survival (OS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE DLBCL
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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

Interventions:
  • Drug: Tafasitamab
  • Drug: Lenalidomide
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2021)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 80 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04974216
Other Study ID Numbers  ICMJE VERLen
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party The Lymphoma Academic Research Organisation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Lymphoma Academic Research Organisation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Lymphoma Academic Research Organisation
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP