A Phase 1, Study of BMF-500 in Adults With Acute Leukemia

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety and tolerability of BMF-500 and to determine the OBD and RP2D of BMF-500.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Key Inclusion Criteria:

- Age ≥ 18 years.

- Individuals with histologically or pathologically confirmed diagnosis of relapsed or
refractory AML, ALL, or MPAL with documented FLT3 mutation, and/or Individuals with
histologically or pathologically confirmed diagnosis of their malignancy with
wild-type FLT3 (including those with MLL1-R and NPM1 mutations).

- ECOG performance status of 0-2.

- Adequate liver and renal function

- Adhere to the CYP3A4 inhibitor concomitant therapy use requirements, as follows:

- Arm A: Participants must not have received a moderate or strong CYP3A4 inhibitor for
at least 7 days prior to enrollment and are not anticipated to require such agents in
the near term (for at least 4 weeks).

- Arm B: Participants must have received a necessary azole antifungal(s) that is a
moderate or strong CYP3A4 inhibitor (excluding other moderate or strong CYP3A4
inhibitor[s]) for at least 7 days prior to enrollment and be able to continue such
azole antifungal(s) while on BMF-500 treatment for at least 4 weeks.

Key Exclusion Criteria:

- Significant cardiovascular disease including unstable angina pectoris, uncontrolled
hypertension or arrhythmia, history of cerebrovascular accident including transient
ischemic attack within 6 months prior to the first dose of the trial intervention.

- WBC count >50,000/µL (uncontrollable with cytoreductive therapy).

- Women who are pregnant or lactating or plan to become pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Kebede Begna, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Cecilia Arana Yi, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Talha Badar, M.B.B.S., M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

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