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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)
NCT02610777 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02610777
The ClinicalTrials.gov registry entry for NCT02610777 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02610777 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02610777?
The interventions under investigation include: Azacitidine (DRUG), Pevonedistat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02610777?
This trial is sponsored by Millennium Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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