Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Blood draws, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients undergo bone marrow biopsy and/or aspiration, and blood sample collection throughout the study."
- "After completion of study treatment, patients are followed up every 3 months for 12 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests venetoclax with a drug treatment called CLAG-M for adults with acute myeloid leukemia (AML) or other serious myeloid blood cancers. It looks for the best dose, checks side effects, and tests how well the drugs work together.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with AML or a high-grade myeloid cancer with at least 10% immature cancer cells in blood or bone marrow. Mixed-type acute leukemia is also allowed.
- Newly diagnosed cancer must meet high-risk study rules. Cancer that returned or did not respond to treatment is allowed only in phase I, must need further treatment, and must meet rules for cancer cells in blood, bone marrow, or a tumor outside the marrow.
- Liver and kidney tests must meet study limits.
- The heart must pump at least 45% of its blood with each beat, with no signs of heart failure.
- Must be able to care for yourself and be out of bed for at least half the day. The study score for risk of death from treatment must be below 13.1.
- White blood cell count must be below 25,000 per microliter before study treatment. Medicine may be used to lower it.
- If able to become pregnant, must have a negative pregnancy test. People who could become pregnant, or whose partners could, must use effective birth control from consent through at least 3 months after the last study dose.
- Must understand the study and agree to sign a consent form.
Who can't join
- Acute promyelocytic leukemia, chronic myeloid leukemia in a phase called myeloid blast crisis, or known active AML in the brain or spinal cord.
- Another illness likely to limit life to less than 1 year.
- An active infection affecting the body, unless treated and controlled or stable. Chronic hepatitis B or C needing treatment, or known HIV infection, also excludes participation.
- Known allergy to any study drug.
- Pregnant or breastfeeding.
- Treatment with another experimental drug, or steroid treatment to fight cancer within 7 days before the first venetoclax dose.
- Unable to stop medicines called CYP3A inhibitors, which affect how drugs are broken down, before treatment starts. Voriconazole is an exception.
- Grapefruit, grapefruit products, Seville oranges (including marmalade), or star fruit within 3 days before the first venetoclax dose.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * PHASE I: * 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 * PHASE II: Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2022 guidelines * Age \>= 18 years * Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3.0 X upper limit of normal (ULN) * Bilirubin =\< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) * 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 * 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 * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Treatment-related mortality (TRM) score \< 13.1 * 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 * Ability to understand and the willingness to sign a written informed consent document * 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 Exclusion Criteria: * 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 * Known hypersensitivity to any study drug * Pregnancy or lactation because of the unknown risks of this combination * Concurrent treatment with any other investigational agent * Subject is known to be positive for human immunodeficiency virus (HIV) * Subjects who cannot discontinue concomitant CYP3A inhibitors, except for voriconazole, prior to cycle 1 day 1 (C1D1) * Treatment with any of the following within 7 days prior to the first dose of venetoclax * Steroid therapy for anti-neoplastic intent * Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax: * Grapefruit or grapefruit products * Seville oranges (including marmalade containing Seville oranges) * Star fruit
Study sites (1)
WA
- Fred Hutch/University of Washington Cancer Consortium · Seattle, WA 98109Kim Quach · Study contact · 206-606-8311 · kquach@fredhutch.orgMary-Beth M. Percival · Study contact · 206-606-1320 · mperciva@fredhutch.orgMary-Beth M. Percival · Principal investigatorMore trials in Seattle