A Phase 1/2, First-in-Human Study of theMenin-KMT2A (MLL1)Inhibitor Bleximenib in Participants with Acute Leukemia
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I
PATOLOGÍA
Coagulopatías hemorrágicas, Linfoma, Leucemia
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Juan Manuel Alonso
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Gabriela Rodríguez Macías
FECHA DE APERTURA
Julio, 2021
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Phase 1 and Phase 2 adult cohorts: 18 years of age and Phase 1 adolescent cohort 12 to <18 years of age
2. Phase 1: R/R acute leukemia and has exhausted, or is ineligible for, available therapeutic options.
3. Phase 1: Acute leukemia harboring KMT2A, NPM1 or nucleoporin alterations. Phase 2: AML harboring KMT2A-r or NPM1 mutations only.
4. Pretreatment clinical laboratory values meeting the criteria
5. ECOG performance status grade of 0, 1 or 2.
6. A female of childbearing potential must have a negative highly sensitive serum -human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
2. Phase 1: R/R acute leukemia and has exhausted, or is ineligible for, available therapeutic options.
3. Phase 1: Acute leukemia harboring KMT2A, NPM1 or nucleoporin alterations. Phase 2: AML harboring KMT2A-r or NPM1 mutations only.
4. Pretreatment clinical laboratory values meeting the criteria
5. ECOG performance status grade of 0, 1 or 2.
6. A female of childbearing potential must have a negative highly sensitive serum -human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
CRITERIOS DE EXCLUSIÓN
1. Diagnosed with acute promyelocytic leukemia, Down syndrome associated leukemia or juvenile myelomonocytic leukemia.
2. Active CNS involvement
3. Prior solid organ transplantation
4. Cardiovascular disease that increases the risk for torsades de pointes or that was diagnosed within 6 months prior to the first dose of study treatment.
5. QTc 450 milliseconds for males or 470 milliseconds for females
6. Any toxicity from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
7. Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
8. Reported temperature >100.5ºF/38ºC within 48 hours prior to the first dose of study treatment
9. Known allergies, hypersensitivity, or intolerance to bleximenib or its excipients.
2. Active CNS involvement
3. Prior solid organ transplantation
4. Cardiovascular disease that increases the risk for torsades de pointes or that was diagnosed within 6 months prior to the first dose of study treatment.
5. QTc 450 milliseconds for males or 470 milliseconds for females
6. Any toxicity from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
7. Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
8. Reported temperature >100.5ºF/38ºC within 48 hours prior to the first dose of study treatment
9. Known allergies, hypersensitivity, or intolerance to bleximenib or its excipients.
DESCRIPCIÓN
Phase 1: Part 1 (Dose Escalation): Determine the (RP2Ds of bleximenib Phase 1: Part 2 (Dose Expansion): Determine the safety and tolerability at the RP2D(s) Phase 2: To evaluate the efficacy of bleximenib at the RP2D
PALABRAS CLAVE
factor xi, leukemia
