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NCT03067571 · ClinicalTrials.gov registry record · Phase 2
Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03067571: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03067571 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03067571, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This phase II trial studies how well daratumumab works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment or high-risk myelodysplastic syndrome. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Response rate as determined by the International Working Group recommendations. Complete remission (CR): The patient must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1.0 x 109/L, platelet count \>/- 100 x 109/L, and normal bone marrow differential (\</= 5% blasts). Complete remission without platelet recovery (CRp): As per CR but platelet count \< 100 x 109/L. Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone
Interventions
- BIOLOGICAL Daratumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 2 |
Why NCT03067571 stopped before completion
NCT03067571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Daratumumab is the first listed.
NCT03067571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03067571 about?
NCT03067571 is a clinical study titled "Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase II trial studies how well daratumumab works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment or high-risk myelodysplastic syndrome. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack t...
What is the current status of trial NCT03067571?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2017-10-27. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT03067571?
The interventions under investigation include: Daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03067571?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03067571's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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