A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04811560
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bleximenib — DRUG
    Bleximenib is administered orally.

Study Details

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Key Dates

Start date
May 19, 2021
Status verified
Jun 2026
Primary completion
Feb 26, 2027
Completion
Sep 22, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Bleximenib
    Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).

Primary Outcome Measure

Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 4 years and 9 months ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California Irvine Medical CenterOrangeCalifornia92868-
UCSF Benioff Children's HospitalSan FranciscoCalifornia94158-
University of California San FranciscoSan FranciscoCalifornia94143-
University of ChicagoChicagoIllinois60637-
St Francis Hospital & Health Centers Indiana Blood and Marrow TransplantationIndianapolisIndiana46237-
Norton Cancer InstituteLouisvilleKentucky40207-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201 2013-
Start MidwestGrand RapidsMichigan49546-
University of New MexicoAlbuquerqueNew Mexico87131-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
NYU Langone Medical CenterNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10467-
Oregon Health And Science UniversityPortlandOregon97239-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Maine HealthProvidenceRhode Island02903-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Baylor University Medical CenterDallasTexas75246-
Houston Methodist HospitalHoustonTexas77030-2740-
MD AndersonHoustonTexas77030-
San Antonio Methodist TX Transplant Physicians GroupSan AntonioTexas78229-
Virginia Commonwealth UniversityRichmondVirginia23298-
Swedish Cancer InstituteSeattleWashington98104-
Medical College of WI at FroedtertMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of California Irvine Medical Center· Orange, CAUCSF Benioff Children's Hospital· San Francisco, CAUniversity of California San Francisco· San Francisco, CAUniversity of Chicago· Chicago, ILSt Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation· Indianapolis, IN

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