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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 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.

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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

Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 52 participants
Start Date 2011-07-01
Est. Completion 2024-09-30
Phase Phase 2

Sponsor

Hetty Carraway

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01305499

The ClinicalTrials.gov registry entry for NCT01305499 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% lower). The listed sponsor is Hetty Carraway, which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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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.