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NCT00968071 · ClinicalTrials.gov registry record · Phase 2

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

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
71
Enrollment target
1
Study location

NCT00968071 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 71 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00968071, 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
71 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.

Interventions

  • DRUG Decitabine
  • DRUG Gemtuzumab Ozogamicin

Study Locations (1)

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2008-02
Est. Completion 2012-08
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00968071

The ClinicalTrials.gov registry entry for NCT00968071 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 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 (66% 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 2 interventions - of which Decitabine is the first listed.

NCT00968071 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00968071 about?

NCT00968071 is a clinical study titled "Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome". The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.

What is the current status of trial NCT00968071?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2008-02. Estimated completion is 2012-08.

What conditions does trial NCT00968071 study?

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

What interventions are being tested in trial NCT00968071?

The interventions under investigation include: Decitabine (DRUG), Gemtuzumab Ozogamicin (DRUG).

Who is sponsoring clinical trial NCT00968071?

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

Where is trial NCT00968071 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.