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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

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 Years and older.

One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.

Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.

Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.

Disqualifiers

Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.

Current or history of central nervous system (CNS) lymphoma.

Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.

Primary mediastinal B-cell lymphoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatinExperimental treatment 4 interventions
Group B: Rituximab in combination with gemcitabine and oxaliplatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

PFS assessed by IRC according to Lugano 2014

Time frame
1-3 years approximately

Secondary outcomes

1

Objective Response Rate (ORR) according to investigator.

Time frame
1-3 years approximately
2

Complete Response Rate (CRR) according to investigator.

Time frame
1-3 years approximately
3

Duration of Response (DOR) according to investigator.

Time frame
1-3 years approximately
4

Progression free survival (PFS) assessed by investigator according to the Lugano 2014

Time frame
1-3 years approximately

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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