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NCT03011034 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Myelodysplastic Syndromes, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 20
- Study locations
NCT03011034: Completed Phase 2 study of Myelodysplastic Syndromes, sponsored by Janssen Research & Development.
NCT03011034 is a Phase 2 study of Myelodysplastic Syndromes that has completed, run by Janssen Research & Development. The registered enrollment target is 34 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011034, a Phase 2 study of Myelodysplastic Syndromes, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.
Conditions Studied
Interventions
- DRUG Daratumumab
- DRUG Talacotuzumab
Study Locations (20)
Other
- ZNA Stuivenberg - Antwerp
- Az Groeninge - Kortrijk
- UZ Leuven - Leuven
- AZ Turnhout - Turnhout
- Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna - Bologna
- Azienda Ospedaliero Universitaria Careggi - Florence
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora - Milan
- Istituto Clinico Humanitas - Rozzano
- UMCG - Groningen
- Erasmus MC - Rotterdam
- Haga ziekenhuis - The Hague
- City Clinical Hospital # 40 - Moscow
- Nizhniy Novgorod Region Clinical Hospital - Nizhny Novgorod
- Saint Petersburg City Hospital #15 - Saint Petersburg
- Hosp Univ Vall D Hebron - Barcelona
- Hosp. Univ. de La Princesa - Madrid
- Hosp Clinico Univ de Salamanca - Salamanca
Missouri
- Washington University School Of Medicine - St Louis
Pennsylvania
- University of Pennsylvania Abramson Cancer Center - Philadelphia
Texas
- University of Texas, MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-02-14 |
| Est. Completion | 2021-10-05 |
| Phase | Phase 2 |
What the finished NCT03011034 record still lists
NCT03011034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Daratumumab is the first listed.
NCT03011034 names 20 study sites across 4 states, led by Other, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03011034 about?
NCT03011034 is a clinical study titled "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". 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 refra...
What is the current status of trial NCT03011034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-02-14. Estimated completion is 2021-10-05.
What conditions does trial NCT03011034 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03011034?
The interventions under investigation include: Daratumumab (DRUG), Talacotuzumab (DRUG).
Who is sponsoring clinical trial NCT03011034?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03011034 being conducted?
This trial has 20 study locations across Missouri, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03011034's enrollment target sits among peer trials
34 114th of 173 higher than 58 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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