OncoMatch/Clinical Trials/NCT04811560
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Is NCT04811560 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Bleximenib for acute leukemias.
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
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: KMT2A (MLL) any alteration
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A)...alterations
Required: NPM1 any alteration
Acute leukemia harboring...nucleophosmin 1 gene (NPM1)...alterations
Required: NUP98 any alteration
Acute leukemia harboring...nucleoporin 98 gene...alterations
Required: NUP214 any alteration
Acute leukemia harboring...nucleoporin 214 gene...alterations
Required: KMT2A (MLL) rearrangement
AML harboring KMT2A-r (gene rearrangement/translocation)...
Required: NPM1 mutation
AML harboring...NPM1 mutations only
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy
relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
Cannot have received: allogenic bone marrow or stem cell transplant
Exception: allowed if >3 months before first dose and no evidence of graft versus host disease
Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; Has evidence of graft versus host disease
Cannot have received: donor lymphocyte infusion
Exception: allowed if >1 month before first dose
Received donor lymphocyte infusion <=1 month before the first dose of study treatment
Cannot have received: immunosuppressant therapy
Exception: daily doses <=10 mg prednisone or equivalent for adrenal replacement are allowed
Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
Cannot have received: cancer immunotherapy
Exception: allowed if >4 weeks prior to enrollment
Prior cancer immunotherapy within 4 weeks prior to enrollment
Cannot have received: blinatumomab (blinatumomab)
Exception: allowed if >2 weeks prior to enrollment
blinatumomab within 2 weeks prior to enrollment
Cannot have received: other cancer therapies
Exception: allowed if >4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
Lab requirements
Blood counts
WBC count <= 20*10^9/L
Kidney function
For adults: eGFR >= 30 mL/min per MDRD; For pediatrics: eGFR >50 mL/min per CKiD Schwartz formula
Cardiac function
QTcF for males < 450 msec, for females < 470 msec; family history of Long QT syndrome excluded
Pretreatment clinical laboratory values: (a) Hematology: WBC count <= 20*10^9/L; (b) renal function: For adults, eGFR >= 30 mL/min per MDRD; For pediatric participants, eGFR >50 mL/min per CKiD Schwartz formula; QTcF for males >= 450 msec or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Phoenix · Goodyear, Arizona
- City of Hope · Duarte, California
- University of California Irvine Medical Center · Orange, California
- University of California San Francisco · San Francisco, California
- UCSF Benioff Children's Hospital · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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