RECRUITING

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

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Conditions

Acute 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms

Quick Facts

Study Start:2022-02-04
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04797767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * PHASE I:
  3. * Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines
  4. * 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.
  5. * These patients are only allowed in the phase 1 portion of the trial
  6. * PHASE II: Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2022 guidelines
  7. * Age \>= 18 years
  8. * Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3.0 X upper limit of normal (ULN)
  9. * Bilirubin =\< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
  10. * Subject must have adequate renal function as demonstrated by a creatinine clearance \>= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
  11. * Left ventricular ejection fraction (LVEF) \>= 45%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 3 months prior to study day 0 or after most recent anthracycline administration if appropriate and no clinical evidence of congestive heart failure
  12. * Eastern Cooperative Oncology Group (ECOG) =\< 2
  13. * Treatment-related mortality (TRM) score \< 13.1
  14. * Female subjects of childbearing potential must have negative results for pregnancy test. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug
  15. * Ability to understand and the willingness to sign a written informed consent document
  16. * White blood cell count in peripheral blood must be \< 25,000/ul prior to initiation of study therapy (CLAG-M plus venetoclax). Cytoreduction with hydroxyurea and/or cytarabine (e.g., 500 mg/m\^2 per dose) is allowed to decrease the risk of tumor lysis syndrome
  1. * Acute promyelocytic leukemia or chronic myeloid leukemia in myeloid blast crisis
  2. * Known active central nervous system (CNS) involvement with acute myeloid leukemia (AML)
  3. * Concomitant illness associated with a likely survival of \< 1 year
  4. * 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
  5. * Known hypersensitivity to any study drug
  6. * Pregnancy or lactation because of the unknown risks of this combination
  7. * Concurrent treatment with any other investigational agent
  8. * Subject is known to be positive for human immunodeficiency virus (HIV)
  9. * Subjects who cannot discontinue concomitant CYP3A inhibitors, except for voriconazole, prior to cycle 1 day 1 (C1D1)
  10. * Treatment with any of the following within 7 days prior to the first dose of venetoclax
  11. * Steroid therapy for anti-neoplastic intent
  12. * Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:
  13. * Grapefruit or grapefruit products
  14. * Seville oranges (including marmalade containing Seville oranges)
  15. * Star fruit

Contacts and Locations

Study Contact

Kim Quach
CONTACT
206.606.8311
kquach@fredhutch.org
Mary-Beth M. Percival
CONTACT
206.606.1320
mperciva@fredhutch.org

Principal Investigator

Mary-Beth M. Percival
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Mary-Beth M. Percival, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-04
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-02-04
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Biphenotypic Leukemia
  • Acute Myeloid Leukemia
  • Mixed Phenotype Acute Leukemia
  • Myeloid Neoplasm
  • Relapsed Acute Biphenotypic Leukemia
  • Relapsed Acute Myeloid Leukemia
  • Relapsed Mixed Phenotype Acute Leukemia
  • Relapsed Myeloid Neoplasm
  • Refractory Acute Biphenotypic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Mixed Phenotype Acute Leukemia
  • Refractory Myeloid Neoplasm
  • Recurrent Myeloid Sarcoma