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NCT01305499 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML)
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Hetty Carraway.
- Active
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 4
- Study locations
NCT01305499: Active Phase 2 study of Acute Myeloid Leukemia, sponsored by Hetty Carraway.
NCT01305499 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Hetty Carraway. The registered enrollment target is 52 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305499, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Hetty Carraway.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research is being done to help us learn how to best use new drugs which may be active against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine) and entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also shown promise in AML. Entinostat has undergone early testing in patients with MDS and AML. It has decreased the blast count in some patients' blood and bone marrow and has improved the blood counts in some patients. The combinations of these two classes of drugs are well tolerated and appear to work well together in laboratory tests. A recent study at Johns Hopkins University administered 5AC and entinostat in an overlapping schedule to patients with myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia (CMMoL), and AML. The impressive results from this study have led to another phase II trial to further examine this drug combination versus 5AC alone in these patients. In this study, we want to see how the timing of when 5AC and entinostat are given affects the magnitude of the disease response.
Conditions Studied
Interventions
- DRUG Entinostat days 3, 10
- DRUG 5AC
- DRUG Entinostat days 10,17
Study Locations (4)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
Connecticut
- Yale School of Medicine - New Haven
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
What the registry record for NCT01305499 still lists
NCT01305499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Entinostat days 3, 10 is the first listed.
NCT01305499 reports a single indexed study location in Ohio, Connecticut, Maryland.
Frequently Asked Questions
What is clinical trial NCT01305499 about?
NCT01305499 is a clinical study titled "A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML)". This research is being done to help us learn how to best use new drugs which may be active against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine) and entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also shown promise in AML. Entinosta...
What is the current status of trial NCT01305499?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2011-07-01. Estimated completion is 2024-09-30.
What conditions does trial NCT01305499 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01305499?
The interventions under investigation include: Entinostat days 3, 10 (DRUG), 5AC (DRUG), Entinostat days 10,17 (DRUG).
Who is sponsoring clinical trial NCT01305499?
This trial is sponsored by Hetty Carraway, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01305499 being conducted?
This trial has 4 study locations across Connecticut, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01305499's enrollment target sits among peer trials
52 138th of 306 higher than 167 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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