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NCT00624936 · ClinicalTrials.gov registry record · Phase 1
Azacytidine and Bortezomib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00624936: Completed Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Ohio State University Comprehensive Cancer Center.
NCT00624936 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 23 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00624936, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as azacytidine work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Giving azacytidine together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when giving together with azacytidine in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes.
Primary Outcome
Determine the maximum tolerated dose (MTD) of Velcade (bortezomib, PS-341) in combination with Vidaza in patients with relapsed/refractory acute myeloid leukemia (AML) and Myelodysplastic Syndrome (MDS)
Conditions Studied
Interventions
- DRUG Velcade
- DRUG Vidaza
Study Locations (1)
Ohio
- Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-04 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT00624936 record still lists
NCT00624936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Velcade is the first listed.
NCT00624936 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00624936 about?
NCT00624936 is a clinical study titled "Azacytidine and Bortezomib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes". RATIONALE: Drugs used in chemotherapy, such as azacytidine work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes...
What is the current status of trial NCT00624936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-04. Estimated completion is 2014-06.
What conditions does trial NCT00624936 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms.
What interventions are being tested in trial NCT00624936?
The interventions under investigation include: Velcade (DRUG), Vidaza (DRUG).
Who is sponsoring clinical trial NCT00624936?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00624936 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00624936's enrollment target sits among peer trials
23 176th of 233 higher than 56 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.
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