Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Conditions

• Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tafasitamab — DRUG
  Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
• Lenalidomide — DRUG
  Lenalidomide PO will be administered as per the schedule specified in the respective arm.
• Rituximab — DRUG
  Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
• Cyclophosphamide — DRUG
  Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
• Doxorubicin — DRUG
  Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine — DRUG
  Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Prednisone — DRUG
  Prednisone PO will be administered as per the schedule specified in the respective arm.
• Tafasitamab placebo — DRUG
  0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
• Lenalidomide placebo — DRUG
  Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.

Study Details

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Key Dates

Start date

May 11, 2021

Status verified

Mar 2026

Primary completion

Sep 1, 2026

Completion

Nov 1, 2027

Study Design

Enrollment

899 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tafasitamab plus lenalidomide in addition to R-CHOP
  Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle
• Placebo Comparator: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP
  Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle Lenalidomide placebo: Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle

Primary Outcome Measure

PFS-INV [ Time Frame: Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months) ]

Locations (47)

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