Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study ID
NCT06521255
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Tafasitamab — DRUG
    Tafasitmab was infused intravenously
  • Lenalidomide — DRUG
    Lenalidomide orally
  • Gemcitabine — DRUG
    Gemcitabine was infused intravenously
  • Oxaliplatin — DRUG
    Oxaliplatin was infused intravenously
  • Rituximab — DRUG
    Rituximab was infused intravenously.

Study Details

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom

Key Dates

Start date
May 7, 2024
Status verified
Jun 2024
Primary completion
Sep 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
  • Active Comparator: Rituximab in combination with gemcitabine and oxaliplatin

Primary Outcome Measure

Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0 [ Time Frame: within 28 days after therapy initiation ]

Central Contacts

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