Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03011034
Phase
PHASE2
Status
Completed

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • Talacotuzumab — DRUG
    Talacotuzumab 9 mg/kg will be administered as an IV infusion.
  • Daratumumab — DRUG
    Daratumumab 16 mg/kg will be administered as an IV infusion.

Study Details

The main purpose of the study is to evaluate the efficacy (transfusion independence \[TI\]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).

Key Dates

Start date
Feb 14, 2017
Status verified
Mar 2025
Primary completion
Jan 23, 2019
Completion
Oct 5, 2021

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Talacotuzumab
    Participants will receive talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 for all cycles. Each treatment cycle is of 28 days. The talacotuzumab arm of the study is closed for enrollment.
  • Experimental: Daratumumab
    Participants will receive daratumumab 16 mg/kg IV on Days 1, 8, 15, and 22 for Cycles 1 and 2; on Days 1 and 15 for Cycles 3 to 6; and on Day 1 for all subsequent cycles. Each treatment cycle is of 28 days.

Primary Outcome Measure

Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks [ Time Frame: Up to 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Washington University School Of MedicineSt LouisMissouri63110-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Texas, MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in St Louis, MO

By research site
Washington University School Of Medicine· St Louis, MOUniversity of Pennsylvania Abramson Cancer Center· Philadelphia, PAUniversity of Texas, MD Anderson Cancer Center· Houston, TX

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