CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Talacotuzumab +1 moredrug
Likely dose
Talacotuzumab 9 mg/kg IV infusion or daratumumab 16 mg/kg IV infusionAI-extracted
Key inclusion· 6
  • ✓Confirmed MDS (WHO criteria) by bone marrow aspirate and biopsy within 12 weeks
  • ✓IPSS low risk or intermediate-1 risk
  • ✓RBC transfusion dependent: ≥4 units over any 8 consecutive weeks in 16 weeks prior to randomization, with pretransfusion Hb ≤9.0 g/dL
  • ✓Adequate iron stores: transferrin saturation >20% and serum ferritin >400 ng/mL, or demonstrated by bone marrow iron stain within 12 weeks
Key exclusion· 5
  • ✕Known allergies or hypersensitivity to talacotuzumab, daratumumab, or excipients
  • ✕Chemotherapy, immunomodulatory/immunosuppressive therapy, or corticosteroids >30 mg/day prednisone equivalent within 28 days prior to randomization
  • ✕Other MDS treatments (azacitidine, decitabine, lenalidomide, ESA) within 28 days (8 weeks for long-acting ESAs)
  • ✕Prior hematopoietic stem cell transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03011034
NCT03011034Phase 2Completed
CompareCT.gov

A Phase 2 Proof-of-Concept Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Janssen Research & Development, LLC·interventional·Posted Jan 5, 2017·Updated Mar 4, 2025

In Brief

A Phase 2 clinical trial evaluating Talacotuzumab and Daratumumab for Myelodysplastic Syndromes. Completed, enrolled 34 participants across 21 sites in 6 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesBelgium, Italy, Netherlands, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartFeb 14, 2017
Primary CompletionJan 23, 2019
Study CompletionOct 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.5 years ago

Interventions

Talacotuzumabdrug

Talacotuzumab 9 mg/kg will be administered as an IV infusion.

Daratumumabdrug

Daratumumab 16 mg/kg will be administered as an IV infusion.