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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: Completed Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Gemtuzumab Ozogamicin
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00968071 record still lists
NCT00968071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT00968071's enrollment target sits among peer trials
71 51st of 134 higher than 84 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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.
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