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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 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.

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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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2016-04-14
Est. Completion 2021-07-23
Phase Phase 2

Sponsor

Millennium Pharmaceuticals

135 total trials

What the Registry Record Tells You About NCT02610777

The ClinicalTrials.gov registry entry for NCT02610777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower). The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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