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NCT01522976 · ClinicalTrials.gov registry record · Phase 2
Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 282
- Enrollment target
- 20
- Study locations
NCT01522976: Active Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
NCT01522976 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 282 participants, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01522976, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 282 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.
Primary Outcome
A response is any of complete hematological remission, partial remission, or hematologic improvement.
Conditions Studied
Interventions
- DRUG Azacitidine
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- DRUG Vorinostat
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- City of Hope Comprehensive Cancer Center - Duarte
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Stanford Cancer Institute Palo Alto - Palo Alto
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente Sacramento Medical Center - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente-San Rafael - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
- Sutter Pacific Medical Foundation - Santa Rosa
Arizona
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- John L McClellan Memorial Veterans Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2012-03-01 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT01522976 still lists
NCT01522976 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (38% higher).
The record links to 7 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Azacitidine is the first listed.
NCT01522976 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01522976 about?
NCT01522976 is a clinical study titled "Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia". This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the gro...
What is the current status of trial NCT01522976?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 282 participants. The study started on 2012-03-01. Estimated completion is 2026-03-19.
What conditions does trial NCT01522976 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome With Excess Blasts, Chronic Myelomonocytic Leukemia-2, Chronic Myelomonocytic Leukemia-1.
What interventions are being tested in trial NCT01522976?
The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01522976?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01522976 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
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 NCT01522976's enrollment target sits among peer trials
282 12th of 134 higher than 123 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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