Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03011034
The ClinicalTrials.gov registry entry for NCT03011034 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (88% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
RECRUITING · Phase 2
-
Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations
RECRUITING · Phase 2
-
Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Ascorbate in Myelodysplastic Syndrome
RECRUITING · Phase 2
-
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.