A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamici… (NCT07052994) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients
United States32 participantsStarted 2027-12-01
Plain-language summary
The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia.
The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.
Who can participate
Age range6 Months – 21 Years
SexALL
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Inclusion criteria
✓. Age . 6 months - 21 years of age.
✓. ECOG performance status of \< 2.
✓. Phase 1a portion of the study: Relapsed/refractory AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NPM1c, NUP98r and UBTF-ITD.
✓. Phase 1b portion of the study: Frontline AML, or MPAL per ELN/NCCN with a myeloid phenotype with KMT2Ar, NUP98r and UBTF-ITD.
✓. WBC must be below 25,000/ ƒÊL at time of enrollment. Patients may receive cytoreduction prior to enrollment.
✓. Baseline ejection fraction must be \> 50%.
✓. Adequate hepatic function (direct bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT \< 5x ULN will be considered eligible).
✓. Potassium should be maintained at . 4.0 mEq/L and magnesium at \> 2.0 mg/dL. Maintenance PO supplementation should be started for patients who are below these thresholds, and Revumenib dosing instructions as provided in Table 2 should be followed.
Exclusion criteria
✕. Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
✕. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
✕. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
✕. Patients with a concurrent active malignancy under treatment.
✕. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
✕. Female subjects who are pregnant or breast-feeding.
✕. Patient has an active uncontrolled infection.
✕. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class .II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.