Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)

Conditions

• Diffuse Large-cell B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plamotamab — BIOLOGICAL
  Biological
• Tafasitamab — BIOLOGICAL
  Biological
• Lenalidomide — DRUG
  Drug

Study Details

The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.

Key Dates

Start date

Apr 15, 2022

Status verified

Apr 2024

Primary completion

Feb 21, 2023

Completion

Feb 21, 2023

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide
  Drug: Plamotamab will be administered at a lower dose in addition to tafasitamab (12 milligrams \[mg\]/kilograms \[kg\] intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially prior to Part 1B.
• Experimental: Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide
  Drug: Plamotamab will be administered at the target dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially after Part 1A.
• Experimental: Part 2A :Plamotamab, Tafasitamab, and Lenalidomide
  Drug: Plamotamab will be administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally).
• Active Comparator: Part 2B: Tafasitamab and Lenalidomide
  Drug: Tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally).

Primary Outcome Measure

Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) ]

Locations (1)

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