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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kebede Begna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cecilia Arana Yi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions