A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Condition(s) studied
Investigational drug(s) / intervention(s)
Bleximenib: Bleximenib is administered orally.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability — Up to 4 years and 9 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. - Phase 1: Number of Participants with AEs by Severity — Up to 4 years and 9 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. - Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT) — Up to 28 days Cycle 1
Percentage of participants with DLT will be assessed accordingly to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5. - Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh) — Up to 4 years and 9 months
Rate of CR/CRh is defined as the percentage of participants achieving a CR or CRh at any time post-treatment.
Trial sites (102)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| University of California Irvine Medical Center | Orange | California | Completed |
| University of California San Francisco | San Francisco | California | Recruiting |
| UCSF Benioff Children's Hospital | San Francisco | California | Recruiting |
| University of Chicago | Chicago | Illinois | Recruiting |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Completed |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Completed |
| Start Midwest | Grand Rapids | Michigan | Recruiting |
| University of New Mexico | Albuquerque | New Mexico | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | Recruiting |
| NYU Langone Medical Center | New York | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| Oregon Health And Science University | Portland | Oregon | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Completed |
| Maine Health | Providence | Rhode Island | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | Recruiting |
| Baylor University Medical Center | Dallas | Texas | Recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| MD Anderson | Houston | Texas | Recruiting |
| San Antonio Methodist TX Transplant Physicians Group | San Antonio | Texas | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Recruiting |
| Medical College of WI at Froedtert | Milwaukee | Wisconsin | Recruiting |
| Monash Medical Centre | Clayton | Australia | Recruiting |
| Royal Perth Hospital | Perth | Australia | Recruiting |
| Gold Coast University Hospital | Southport | Australia | Recruiting |
| Ghent University Hospital | Ghent | Belgium | Recruiting |
| IDOR - Regional Brasilia | Brasília | Brazil | Recruiting |
| Liga Norte Riograndense Contra O Cancer | Natal | Brazil | Recruiting |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | Brazil | Recruiting |
| Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo | São Paulo | Brazil | Recruiting |
| IDOR - Regional Sao Paulo | São Paulo | Brazil | Recruiting |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | Brazil | Recruiting |
| Vancouver Coastal Health | Vancouver | British Columbia | Recruiting |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | Recruiting |
| Hopital Maisonneuve Rosemont | Montreal | Quebec | Recruiting |
| Peking University First Hospital | Beijing | China | Recruiting |
+ 62 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04811560 on ClinicalTrials.gov ↗ ← All trials in South Korea