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NCT00326170 · ClinicalTrials.gov registry record · Phase 2

Phase II 5-Azacytidine Plus VPA Plus ATRA

A Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target
1
Study location

NCT00326170 is a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00326170, a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target
1
Study location

Study Summary

5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.

Conditions Studied

Myelodysplastic Syndrome Acute Myelogenous Leukemia

Interventions

  • DRUG Valproic Acid
  • DRUG All-Trans Retinoic Acid (ATRA)
  • DRUG 5-Azacytidine (5-aza)

Study Locations (1)

Texas

  • The University of Texas M.D. Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2005-07
Est. Completion 2007-12
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00326170

The ClinicalTrials.gov registry entry for NCT00326170 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (84% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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

NCT00326170 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00326170 about?

NCT00326170 is a clinical study titled "Phase II 5-Azacytidine Plus VPA Plus ATRA". 5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA)...

What is the current status of trial NCT00326170?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2005-07. Estimated completion is 2007-12.

What conditions does trial NCT00326170 study?

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

What interventions are being tested in trial NCT00326170?

The interventions under investigation include: Valproic Acid (DRUG), All-Trans Retinoic Acid (ATRA) (DRUG), 5-Azacytidine (5-aza) (DRUG).

Who is sponsoring clinical trial NCT00326170?

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

Where is trial NCT00326170 being conducted?

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

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