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NCT00882102 · ClinicalTrials.gov registry record · Phase 2

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target

NCT00882102: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00882102 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00882102, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study Summary

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

Primary Outcome

Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).

Interventions

  • DRUG Decitabine
  • DRUG Gemtuzumab ozogamicin

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2009-04
Est. Completion 2012-08
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00882102 record still lists

NCT00882102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.

NCT00882102 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00882102 about?

NCT00882102 is a clinical study titled "Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)". The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety of this drug combination...

What is the current status of trial NCT00882102?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2009-04. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00882102?

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

Who is sponsoring clinical trial NCT00882102?

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

How this trial's enrollment target compares

Where NCT00882102's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00882102, the US trial registry maintained by the National Library of Medicine. NCT00882102 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.