Phase 2
Completed N=34
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
Source: ClinicalTrials.gov NCT03011034 ↗Enrolled (actual)
34
Serious AEs
47.1%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks — 0; 6.1 Percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks |
0; 6.1 | — |
| SECONDARY Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks |
0; 3.0 | — |
| SECONDARY Time to Transfusion Independence (TI) |
4; 5; NA | — |
| SECONDARY Duration of Transfusion Independence (TI) |
16; 65; NA | — |
| SECONDARY Percentage of Participants Who Met IWG Criteria for Transfusion Reduction |
0; 54.5 | — |
| SECONDARY Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage |
0; 9.1 | — |
| SECONDARY Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment |
0; 9.1; 0; 0.0; 0; 0.0 | — |
| SECONDARY Percentage of Participants With Complete Remission (CR) and Marrow CR |
0; 0; 0; 3.0 | — |
| SECONDARY Percentage of Participants With Partial Remission (PR) |
0; 0 | — |
| SECONDARY Percentage of Participants With Cytogenetic Response |
0; 0 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Time to Progression to Acute Myeloid Leukemia (AML) |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to first dose. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be approved by the sponsor
- International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS
- Red blood cell (RBC) transfusion dependent, 1) Received at least 4 units of RBCs over any 8 consecutive weeks during the 16 weeks prior to randomization, 2) Pretransfusion Hb must have been less than or equal to ( ]30 milligram per day [mg/day] prednisone or equivalent) within 28 days prior to randomization
- Received other treatments for MDS within 28 days prior to first dose (example [eg], azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks for long-acting ESAs)
- History of hematopoietic stem cell transplant
- Del(5q) karyotype unless treatment with lenalidomide has failed. Failure is defined as either: 1) having received at least 3 months of lenalidomide treatment without RBC transfusion benefit (International Working Group [IWG] 2006); 2) progression or relapse after hematologic improvement with lenalidomide (IWG 2006); 3) discontinuation of lenalidomide due to toxicity; or 4) unable to receive lenalidomide due to a contraindication. Source documentation for lenalidomide treatment failure must be verified by the sponsor
Data sourced from ClinicalTrials.gov (NCT03011034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.