What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include induction chemotherapy with cytarabine and anthracyclines (e.g., daunorubicin or idarubicin), and for patients with FLT3 mutations, the addition of FLT3 inhibitors like midostaurin. Known side effects of these treatments include severe cytopenias, infections, bleeding, tumor lysis syndrome, and electrolyte imbalances. Specific to FLT3 inhibitors, side effects can include gastrointestinal disturbances, liver enzyme abnormalities, and QT interval prolongation. These treatments require careful monitoring and management of complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents like azacitidine and decitabine, which are used to improve survival and response rates. Venetoclax, often combined with these agents, has also shown superior outcomes. For FLT3-mutated AML, midostaurin and gilteritinib are FDA-approved FLT3 inhibitors that target the same pathway as BMF-500, aiming to improve remission rates and overall survival in patients with FLT3 mutations.

What other types of research exist?

Promising novel alternatives to BMF-500 for AML patients include hypomethylating agents (HMAs) such as azacitidine and decitabine, which have shown comparable efficacy and tolerability. Combination therapies like low-dose cytarabine (LoDAC) with venetoclax or glasdegib are also promising due to superior outcomes compared to LoDAC monotherapy.

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Tyrosine Kinase Inhibitor

BMF-500 for Leukemia

Phase 1

Recruiting

Research Sponsored by Biomea Fusion Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of each 28 day cycle for a maximum of 32 cycles

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing BMF-500, a pill that blocks a protein called FLT3, in adults with aggressive types of leukemia. The goal is to stop cancer cells from growing by blocking this protein.

Who is the study for?

Adults over 18 with acute leukemia (AML, ALL, or MPAL) that has come back or didn't respond to treatment. They must have a FLT3 mutation and be able to follow rules about using certain other drugs. People can't join if they have very high white blood cell counts, serious heart problems, recent strokes, or are pregnant.

What is being tested?

The trial is testing BMF-500, an oral drug for acute leukemia targeting the FLT3 gene mutation. It's a first-in-human study where doses will gradually increase to find safe levels before expanding to more patients.

What are the potential side effects?

Specific side effects of BMF-500 aren't listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, liver issues and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of each 28 day cycle for a maximum of 32 cycles

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of each 28 day cycle for a maximum of 32 cycles

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each 28 day cycle for a maximum of 32 cycles for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the recommended Phase 2 Dose (RP2D) of BMF-500.

Evaluate the safety and tolerability of BMF-500 monotherapy by incidence of Serious Adverse Events (SAEs).

Evaluate the safety and tolerability of BMF-500 monotherapy by incidence of Treatment Emerging Adverse Events (TEAEs).

Secondary study objectives

Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.

Assess the effect of food on the PK exposure of BMF-500 in participants receiving BMF-500 (for escalation only).

Determine the pharmacokinetics of BMF-500.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion PhaseExperimental Treatment1 Intervention

BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity or who are receiving necessary azole antifungals that are moderate or strong CYP3A4 inhibitors excluding other moderate or strong CYP3A4 inhibitors.

Group II: Escalation PhaseExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Myeloid Leukemia (AML) include FLT3 inhibitors, cytarabine, daunorubicin, and clofarabine. FLT3 inhibitors, such as the investigational drug BMF-500, target mutations in the FLT3 gene, which are common in AML and associated with poor prognosis. By inhibiting the FLT3 protein, these drugs can reduce the proliferation of leukemic cells. Cytarabine and daunorubicin, often used in combination, work by interfering with DNA synthesis and inducing cell death in rapidly dividing cells. Clofarabine, another chemotherapeutic agent, inhibits DNA synthesis and repair, leading to cell death. These treatments are crucial as they target the rapid and uncontrolled growth of leukemic cells, aiming to achieve remission and improve survival rates in AML patients.