What side effects are associated with this type of intervention?

Common treatments for leukemia, including imatinib, dasatinib, and bosutinib, have a range of side effects. Imatinib can cause nausea, diarrhea, muscle cramps, skin rash, and myelosuppression (thrombocytopenia and neutropenia). Dasatinib is generally well-tolerated but can cause fluid retention and myelosuppression. Bosutinib's side effects include diarrhea, rash, and vomiting. Revumenib, a Menin-MLL1 interaction inhibitor, is being studied for its safety and tolerability in combination with chemotherapy, but specific side effects are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for leukemia, particularly for acute myeloid leukemia (AML) with specific genetic mutations. For instance, venetoclax, a BCL-2 inhibitor, is approved for use in combination with hypomethylating agents like azacitidine or decitabine for newly diagnosed AML in adults who are 75 years or older or have comorbidities precluding intensive induction chemotherapy. Ivosidenib, an IDH1 inhibitor, and enasidenib, an IDH2 inhibitor, are approved for relapsed or refractory AML with IDH1 and IDH2 mutations, respectively. Gilteritinib, a FLT3 inhibitor, is approved for relapsed or refractory AML with FLT3 mutations. These treatments, like Revumenib, target specific molecular abnormalities in leukemia cells, offering a more personalized approach to therapy.

What other types of research exist?

Promising novel alternatives to Revumenib for leukemia patients include: 1) Venetoclax-based regimens, which are being studied for both frontline therapy in younger AML patients and in relapsed/refractory AML patients. 2) Combination BRAF and MEK1/2 inhibitors, which have shown complete hematologic response in CML patients with concomitant metastatic melanoma. These alternatives are currently under investigation and may offer new treatment options in 2024.

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SNDX-5613 + Chemotherapy for Leukemia

Phase 1

Waitlist Available

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Participants must have documented relapsed or refractory (R/R) AML, ALL, or acute leukemias of ambiguous lineage (ALAL) including MPAL and acute undifferentiated leukemia (AUL) harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.

Participant must be taking 1 of the following medications for antifungal prophylaxis: itraconazole, ketoconazole, posaconazole, or voriconazole.

Must not have

Any unresolved ≥Grade 2 reversible toxicity from previous anticancer therapy except alopecia or Grade 2 neuropathy

Any gastrointestinal (GI) issue of the upper GI tract that might affect oral drug absorption or ingestion (for example, gastric bypass, gastroparesis).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called revumenib combined with chemotherapy in patients whose leukemia has returned or did not respond to previous treatments and have specific genetic changes. The drug aims to block these genetic changes to make the chemotherapy more effective.

Who is the study for?

This trial is for people with certain types of acute leukemia that have come back or haven't responded to treatment. They must be on specific antifungal meds, agree to contraception if they can have children, and have a white blood count under control. Good performance status and proper liver/heart function are required.

What is being tested?

The study tests the safety of SNDX-5613 combined with two chemotherapy regimens in patients with relapsed/refractory acute leukemias who have specific genetic changes related to their cancer.

What are the potential side effects?

While not specified here, common side effects from similar treatments may include nausea, fatigue, increased risk of infection due to low blood cell counts, hair loss from chemotherapy, and potential liver or heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia has returned or didn't respond to treatment and has specific genetic changes.

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I am currently taking an antifungal medication like itraconazole.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have lasting side effects from cancer treatment, except for hair loss or mild nerve issues.

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I have a stomach or upper GI issue that could affect how I absorb pills.

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I haven't had serious heart issues like a heart attack or stroke in the last 6 months.

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I have a genetic condition known to cause bone marrow failure.

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I haven't had biologic therapy for at least 28 days or 5 half-lives, whichever is longer.

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I have Down Syndrome.

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My liver disease is severe, with a Child-Pugh score of B or C.

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I have Hepatitis B.

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I have Hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Revumenib and Chemotherapy Regimen 2Experimental Treatment2 Interventions

Participants with ALL/MPAL or acute myeloid leukemia (AML) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 2.

Group II: Revumenib and Chemotherapy Regimen 1Experimental Treatment2 Interventions

Participants with acute lymphoblastic leukemia/mixed phenotype acute leukemia (ALL/MPAL) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Revumenib

2022

Completed Phase 1

~30

Chemotherapy Regimen 1

2022

Completed Phase 1

~30

Chemotherapy Regimen 2

2022

Completed Phase 1

~30

0 / 12Eligibility criteria met

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

Leukemia treatments often target specific genetic mutations or pathways involved in the proliferation and survival of cancer cells. For instance, Revumenib, a Menin-MLL1 interaction inhibitor, disrupts the interaction between menin and MLL1, which is crucial for the growth of leukemic cells with MLL rearrangements or NPM1 mutations. This inhibition can halt the proliferation of these cancer cells, leading to their death. Other treatments, like FLT3 inhibitors, target mutations in the FLT3 gene, which are common in acute myeloid leukemia (AML) and drive cancer cell growth. By understanding and targeting these specific mechanisms, treatments can be more effective and personalized, potentially leading to better outcomes for leukemia patients.

Therapeutic targeting of preleukemia cells in a mouse model of NPM1 mutant acute myeloid leukemia.Synergistic targeting of FLT3 mutations in AML via combined menin-MLL and FLT3 inhibition.