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NCT02610777 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
A Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT02610777: Completed Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Millennium Pharmaceuticals.
NCT02610777 is a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 120 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02610777, a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored at the date the participant was last known to be alive. The Kaplan Meier estimates was used for the analysis.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Pevonedistat
Study Locations (20)
New York
- Monter Cancer Center - Lake Success
- Weill Cornell Medical College - New York
- Columbia University Medical Center - New York
- University of Rochester Medical Center - Rochester
Texas
- Cancer Care Center of South Texas - New Braunfels
- Nebraska Cancer Specialists - The Woodlands
- Texas Oncology - Waco, TX - Tyler
California
- UC San Diego Moores Cancer Center - La Jolla
- Compassionate Cancer Care Medical Group Incorporated - Riverside
Florida
- University of Miami Miller School of Medicine - Miami
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Alabama
- University of Alabama - Birmingham
Arkansas
- Greenville Health System - Little Rock
Colorado
- Rocky Mountain Cancer Centers - Aurora
Connecticut
- Smilow Cancer Center at Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2016-04-14 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 2 |
What the finished NCT02610777 record still lists
NCT02610777 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower).
The record links to 3 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT02610777 names 20 study sites across 13 states, led by New York, Texas, California.
Frequently Asked Questions
What is clinical trial NCT02610777 about?
NCT02610777 is a clinical study titled "An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)". The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
What is the current status of trial NCT02610777?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2016-04-14. Estimated completion is 2021-07-23.
What conditions does trial NCT02610777 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic.
What interventions are being tested in trial NCT02610777?
The interventions under investigation include: Azacitidine (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT02610777?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02610777 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
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Where NCT02610777's enrollment target sits among peer trials
120 45th of 173 higher than 128 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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