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A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene

NCT02141828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-06-18

No results posted yet for this study

Summary

A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of patients with MLL-rearranged leukemias.

Conditions

Interventions

DRUG

EPZ-5676

28-day continuous IV infusion of each 28-day cycle, given until disease progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Neal Shukla, MD · Memorial Sloan Kettering Cancer Center

  • Lia Gore, MD · Children's Hospital Colorado

  • Pat Brown, MD · Johns Hopkins University

  • Lewis Silverman, MD · Dana Farber

  • Maureen O'Brien, MD · Children's Hospital Medical Center, Cincinnati

  • Jim A Whitlock, MD · Hospital of Sick Kids

  • Cynthia Wetmore, MD PhD · Emory Children's Healthcare of Atlanta

  • Mignon Loh, MD · University of California, San Francisco

  • Paul Gaynon, MD · Children's Hospital Los Angeles

  • Todd Cooper, MD · Seattle Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141828 on ClinicalTrials.gov