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NCT01542684 · ClinicalTrials.gov registry record · Phase 2
Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01542684: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01542684 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542684, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied. Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.
Primary Outcome
ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blast
Interventions
- DRUG Azacytidine
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
Why NCT01542684 stopped before completion
NCT01542684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacytidine is the first listed.
NCT01542684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542684 about?
NCT01542684 is a clinical study titled "Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied. Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins...
What is the current status of trial NCT01542684?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2012-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01542684?
The interventions under investigation include: Azacytidine (DRUG), GM-CSF (DRUG).
Who is sponsoring clinical trial NCT01542684?
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 NCT01542684's enrollment target sits among peer trials
8 1990th 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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