OncoMatch/Clinical Trials/NCT04811560
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Is NCT04811560 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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 →Frequently asked questions
Is NCT04811560 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogenic bone marrow or stem cell transplant, donor lymphocyte infusion, immunosuppressant therapy disqualifies patients from enrollment.
Does this trial require KMT2A?
Yes, KMT2A any alteration is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 any alteration is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 any 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