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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT04974216
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
80 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tafasitamab — DRUG
    Administration : IV at 12mg/Kg C1 to C3: D1, D8, D15, D22 C4 to C6: D1, D15 C7 to C12: D1
  • Lenalidomide — DRUG
    Oral administration: hard capsule C1 to C6: 20mg/day C7 to C12: 15mg/day
  • Rituximab — DRUG
    Administration: IV at 375mg/m2 C1 to C6: D1

Study Details

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.

Key Dates

Start date
Dec 20, 2021
Status verified
Jun 2026
Primary completion
Jul 15, 2024
Completion
Jun 30, 2027

Study Design

Enrollment
71 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall Response Rate (ORR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]

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