Spots Global Cancer Trial Database for A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
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Trial Identification
Brief Title: A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Official Title: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
Study ID: NCT04065399
Study Description
Brief Summary: Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.
Detailed Description: Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib to identify the MTD and RP2D. Participants will be enrolled in one of six dose-escalation arms: Arm A: Participants not receiving any strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers or fluconazole. Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis. Arm C: Participants receiving revumenib and cobicistat. Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis. Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers. Arm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis. In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib: * Cohort 2A: Participants with KMT2Ar acute lymphoblastic leukemia (ALL)/mixed phenotype acute leukemia (MPAL) * Cohort 2B: Participants with KMT2A AML * Cohort 2C: Participants with NPM1m AML
Eligibility
Minimum Age: 30 Days
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital, Los Angeles, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
University of Colorado, Aurora, Colorado, United States
Florida Cancer Specialists and Research Institute, Sarasota, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
University of Iowa hospital, Iowa City, Iowa, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University in St. Louis School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Montefiore Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
Peter MacCallum Cancer Centre (PMCC), Melbourne, Victoria, Australia
Royal Melbourne Hospital (RMH), Parkville, Victoria, Australia
Alfred Hospital, Melbourne, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
Royal North Shore Hospital, Saint Leonards, , Australia
University Health Network, Toronto, , Canada
The Hospital for Sick Children, Toronto, , Canada
Centre Hospitalier Lyon Sud, Pierre-Benite, , France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP, Villejuif, , France
Universitaetsklinikum Essen (AoR), Essen, , Germany
Universitaetsmedizin Greifswald, Greifswald, , Germany
Universitaetsmedizin Der Johannes, Gutenberg, , Germany
Rambam Health Care Campus (RHCC, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center- Ein Kerem, Jerusalem, , Israel
Galilee Medical Center, Nahariya, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
Istituto Romagnolo Per Lo Studio dei tumori Dino Amadori, Meldola, , Italy
S Bortolo Hospital AULSS 8 Berica, Vicenza, , Italy
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
Princess Maxima Center for Pediatric Oncology, Utrecht, , Netherlands
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals, Hospitalet De Llobregat, , Spain
Hospital Universitario Virgen del Rocio, Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Contact Details
Name: Angela R Smith, M.D.
Affiliation: Syndax Pharmaceuticals
Role: STUDY_DIRECTOR
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