What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL) often include chemotherapy, targeted therapy, and sometimes radiation therapy. General side effects of these treatments can include myelosuppression (leading to anemia, neutropenia, and thrombocytopenia), gastrointestinal symptoms (nausea, vomiting, diarrhea), mucositis, fatigue, and increased risk of infections. For treatments similar to BMF-219, which is an oral covalent menin inhibitor, specific side effects may include gastrointestinal disturbances, hematologic toxicities (such as leukopenia and thrombocytopenia), and potential liver toxicity. As with many targeted therapies, the side effect profile can vary based on the specific mechanism of action and patient response.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Acute Lymphoblastic Leukemia (ALL). These include tyrosine kinase inhibitors like imatinib and dasatinib for Philadelphia chromosome-positive ALL. Additionally, blinatumomab, a bispecific T-cell engager, and inotuzumab ozogamicin, an antibody-drug conjugate, have been approved for relapsed or refractory ALL. While specific information on menin inhibitors like BMF-219 is not available, these approvals highlight the trend towards targeted therapies in ALL treatment.

What other types of research exist?

Promising novel alternatives to BMF-219 for Acute Lymphoblastic Leukemia (ALL) patients include: 1) Venetoclax in combination with azacitidine, which has shown encouraging efficacy in relapsed/refractory AML and could be considered for ALL. 2) Imatinib, a tyrosine kinase inhibitor, which has demonstrated efficacy in Philadelphia chromosome-positive ALL in children. These alternatives have shown potential in clinical trials and could be considered for treatment in 2024.

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Menin Inhibitor

BMF-219 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Biomea Fusion

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 cycle 1 (each cycle is 28 days in duration)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug called BMF-219 that blocks a protein involved in cancer growth. It is aimed at adults with specific types of blood cancers that have certain genetic changes. The goal is to see if this drug can stop the cancer cells from growing.

Who is the study for?

Adults with certain blood cancers like AML, ALL with specific mutations, DLBCL, MM, and CLL/SLL can join this trial. They must have relapsed or refractory cancer despite previous treatments, be over 18 years old with good organ function and willing to use birth control. People are excluded if they have active CNS involvement by their cancer or a history of certain other conditions.

What is being tested?

The study is testing BMF-219, an oral drug designed to block menin's action in the body. It's for adults who've seen their blood cancer return or not respond to treatment. The trial will gradually increase doses to find the safest and most effective level.

What are the potential side effects?

As a first-in-human study for BMF-219, detailed side effects aren't listed but may include typical reactions related to immune system changes such as fatigue, nausea, fever; organ-specific inflammation; allergic reactions; and potential impact on blood cell counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 1 (each cycle is 28 days in duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 1 (each cycle is 28 days in duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 1 (each cycle is 28 days in duration) 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 Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4)

Secondary study objectives

Therapeutic procedure

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: Dose ExpansionExperimental Treatment1 Intervention

Experimental: ARM B: Study participants who are receiving a moderate or strong CYP3A4 inhibitor. Dose Escalation Phase: • Cohort 1: Participants with acute leukemia will receive escalating dose BMF-219 orally to identify the OBD/ RP2D (Optimal Biologic Dose/Recommended Ph2 Dose). Dose Expansion Phase: Cohort 1 will receive BMF-219 at the OBD/ RP2D to further assess the safety and efficacy of the investigational drug.

Group II: Dose Escalation PhaseExperimental Treatment1 Intervention

Experimental: ARM A: Study participants who are not receiving a moderate or strong CYP3A4 inhibitor. Dose Escalation Phase: * Cohort 1: Participants with acute leukemia * Cohort 2: Participants with diffuse large B-cell lymphoma * Cohort 3: Participants with multiple myeloma * Cohort 4: Participants with chronic lymphocytic leukemia/ small lymphocytic lymphoma Participants will receive escalating dose BMF-219 orally once per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose). Dose Expansion Phase: Cohorts 1, 2, 3, and 4 will receive BMF-219 at the OBD/ RP2D to further assess the safety/ efficacy of the investigational drug.

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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 Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors (e.g., imatinib, dasatinib), specifically inhibit proteins involved in cancer cell growth and survival, offering a more precise approach with potentially fewer side effects. Immunotherapy, including CAR-T cell therapy, harnesses the patient's immune system to recognize and destroy leukemia cells. The importance of these mechanisms lies in their ability to reduce the leukemia cell burden and achieve remission. Treatments like BMF-219, an oral covalent menin inhibitor, represent a novel approach by targeting specific genetic and molecular pathways involved in leukemia, potentially overcoming resistance to conventional therapies and improving outcomes for ALL patients.

Emerging treatments in acute lymphoblastic leukemia.