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Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

ConditionsAcute Biphenotypic LeukemiaAcute Myeloid LeukemiaMixed Phenotype Acute LeukemiaMyeloid NeoplasmRelapsed Acute Biphenotypic LeukemiaRelapsed Acute Myeloid LeukemiaRelapsed Mixed Phenotype Acute LeukemiaRelapsed Myeloid NeoplasmRefractory Acute Biphenotypic LeukemiaRefractory Acute Myeloid LeukemiaRefractory Mixed Phenotype Acute LeukemiaRefractory Myeloid NeoplasmRecurrent Myeloid Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with CLAG-M may kill more cancer cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of acute myeloid leukemia (per the World Health Organization [WHO] 2016 classification) or high-grade myeloid neoplasm (>= 10% myeloid blasts in peripheral blood or marrow as assessed by morphology or multiparameter flow cytometry at initial presentation). Patients with biphenotypic or mixed phenotype acute leukemia are eligible.

Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines

Relapsed/refractory patients presenting for trial entry must require first or subsequent salvage therapy and have detectable blasts in peripheral blood or >= 5% blasts in bone marrow, as assessed by morphology or multiparameter flow cytometry; or extramedullary myeloid sarcoma, per European LeukemiaNet 2017 guidelines.

These patients are only allowed in the phase 1 portion of the trial

Disqualifiers

Acute promyelocytic leukemia or chronic myeloid leukemia in myeloid blast crisis

Known active central nervous system (CNS) involvement with acute myeloid leukemia (AML)

Concomitant illness associated with a likely survival of < 1 year

Active systemic infection, unless disease is under treatment with antimicrobials and considered controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible. Patients with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment would be excluded. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface [HBs] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core [HBc] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate

Trial design

Design model

Single group

Treatments tested in this trial

  • Cladribine

    Drug

    Given IV

  • Cytarabine

    Drug

    Given IV

  • Mitoxantrone

    Drug

    Given IV

  • Recombinant Granulocyte Colony-Stimulating Factor

    Biological/Vaccine

    Given subcutaneously

  • Venetoclax

    Drug

    Given PO

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Treatment (CLAG-M, venetoclax)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (Phase I)

Time frame
Up to 12 months
2

Maximum tolerated dose of venetoclax in combination with CLAG-M (Phase I)

Time frame
Up to 12 months
3

Event free survival (Phase II)

Time frame
At 6 months

Secondary outcomes

1

Complete remission rate

Time frame
After 2 cycles (each cycle is approximately 35 days)
2

Rate of minimal residual disease negativity

Time frame
Up to 1 year
3

Rate of allogeneic hematopoietic cell transplant

Time frame
At 1 year
4

Overall survival

Time frame
At 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov
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