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
Completed · Phase 2
Conditions studied: Myelodysplastic Syndromes
In brief
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 facts
- Study ID
- NCT03011034
- Run by
- Janssen Research & Development, LLC
- People needed
- 34
- Starts
- 2017-02-14
- Expected to finish
- 2021-10-05
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 (<=)9.0 gram per deciliter (g/dL)
- Adequate iron stores, defined as transferrin saturation greater than 20 percent (%) and serum ferritin greater than 400 nanogram per Milliliter (ng/mL), measured within the screening period, or adequate iron stores as demonstrated by recent (within 12 weeks prior to first dose) bone marrow examination with iron stain
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
You may not qualify if…
- Known allergies, hypersensitivity, or intolerance to talacotuzumab and daratumumab or their excipients
- Received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids (greater than [>]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
Where it is running
- Washington University School Of Medicine — St Louis, Missouri, United States
- University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
- University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
- ZNA Stuivenberg — Antwerp, Belgium
- Az Groeninge — Kortrijk, Belgium
- UZ Leuven — Leuven, Belgium
- AZ Turnhout — Turnhout, Belgium
- Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna — Bologna, Italy
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora — Milan, Italy
- Istituto Clinico Humanitas — Rozzano, Italy
- UMCG — Groningen, Netherlands
- Erasmus MC — Rotterdam, Netherlands
- Haga ziekenhuis — The Hague, Netherlands
- City Clinical Hospital # 40 — Moscow, Russia
- Nizhniy Novgorod Region Clinical Hospital — Nizhny Novgorod, Russia
- Saint Petersburg City Hospital #15 — Saint Petersburg, Russia
- Hosp Univ Vall D Hebron — Barcelona, Spain
- Hosp. Univ. de La Princesa — Madrid, Spain
- Hosp Clinico Univ de Salamanca — Salamanca, Spain
- Hosp. Univ. I Politecni La Fe — Valencia, Spain
Full record on ClinicalTrials.gov
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