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NCT00569010 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

A Phase 1 study of Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT00569010: Completed Phase 1 study of Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.

NCT00569010 is a Phase 1 study of Leukemia and Myelodysplastic Syndrome that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00569010, a Phase 1 study of Leukemia and Myelodysplastic Syndrome, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of Azacytidine (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The safety and effectiveness of this treatment combination will also be studied.

Primary Outcome

Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (\< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.

Interventions

  • DRUG Azacitidine
  • DRUG Ara-C

Study Locations (1)

Texas

  • U.T.M.D. Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2005-12
Est. Completion 2009-10
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00569010 record still lists

NCT00569010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (93% lower).

The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.

NCT00569010 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00569010 about?

NCT00569010 is a clinical study titled "Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to find the highest tolerable dose of Azacytidine (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The safety ...

What is the current status of trial NCT00569010?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2005-12. Estimated completion is 2009-10.

What conditions does trial NCT00569010 study?

This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndrome, Acute Myelogenous Leukemia.

What interventions are being tested in trial NCT00569010?

The interventions under investigation include: Azacitidine (DRUG), Ara-C (DRUG).

Who is sponsoring clinical trial NCT00569010?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00569010 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Leukemia

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.

Where NCT00569010's enrollment target sits among peer trials

36 146th of 233 higher than 86 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00569010, the US trial registry maintained by the National Library of Medicine. NCT00569010 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.