OncoMatch/Clinical Trials/NCT04811560
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Is NCT04811560 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Bleximenib for acute leukemia.
Treatment: Bleximenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: KMT2A (MLL) alteration
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A)...alterations
Required: NPM1 alteration
Acute leukemia harboring...nucleophosmin 1 gene (NPM1)...alterations
Required: NUP98 alteration
Acute leukemia harboring...nucleoporin 98 gene...alterations
Required: NUP214 alteration
Acute leukemia harboring...nucleoporin 214 gene...alterations
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Blood counts
white blood cell (WBC) count <= 20*10^9/liter (L)
Kidney function
For adult participants, estimated or measured glomerular filtration rate >= 30 mL/min per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate >=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count <= 20*10^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate >= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate >=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
- Montefiore Medical Center · The Bronx, New York
- Oregon Health And Science University · Portland, Oregon
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
- Maine Health · Providence, Rhode Island
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04811560 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require KMT2A?
Yes, KMT2A alteration is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 alteration is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 alteration is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify