Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT02141828
Interventions
Study Description
Brief 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.
Detailed Description: This is a Phase 1b study of EPZ-5676 in pediatric patients. The study will have two phases. The first phase will assess escalating doses of EPZ-5676 in order to determine the maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of EPZ-5676 as a 28-day continuous IV infusion. Once the MTD and/or RP2D is established, a second phase of the study will further evaluate the safety of EPZ-5676 and assess the anti-leukemia activity.
Eligibility
Minimum Age: 3 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
University of California San Francisco Medical Center-Parnassus, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Emory Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
The Hospital for Sick Kids, Toronto, Ontario, Canada
Contact Details
Name: Neal Shukla, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Lia Gore, MD
Affiliation: Children's Hospital Colorado
Role: PRINCIPAL_INVESTIGATOR
Name: Pat Brown, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: Lewis Silverman, MD
Affiliation: Dana Farber
Role: PRINCIPAL_INVESTIGATOR
Name: Maureen O'Brien, MD
Affiliation: Children's Hospital Medical Center, Cincinnati
Role: PRINCIPAL_INVESTIGATOR
Name: Jim A Whitlock, MD
Affiliation: Hospital of Sick Kids
Role: PRINCIPAL_INVESTIGATOR
Name: Cynthia Wetmore, MD PhD
Affiliation: Emory Children's Healthcare of Atlanta
Role: PRINCIPAL_INVESTIGATOR
Name: Mignon Loh, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
Name: Paul Gaynon, MD
Affiliation: Children's Hospital Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Todd Cooper, MD
Affiliation: Seattle Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
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