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New treatment option for Acute Biphenotypic Leukemia
Official title Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
ClinicalTrials.gov ID: NCT04797767
What this study is testing
What is Cladribine?
Cladribine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute biphenotypic leukemia.
Also referred to as 2-CdA, 2CDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of acute myeloid leukemia (per the World Health Organization [WHO] 2016 classification) or high-grade myeloid neoplasm (\>= 10% myeloid...
- 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...
- These patients are only allowed in the phase 1 portion of the trial
You likely can't join if
- 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...
- Known hypersensitivity to any study drug
- Pregnancy or lactation because of the unknown risks of this combination
See the full eligibility 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...
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) =\< 2
- Treatment-related mortality (TRM) score \< 13.1
- Female people of childbearing potential must have negative results for pregnancy test. Female people of childbearing potential and male people with female partners of childbearing potential must agree to use an...
- 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...
- 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...
- 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)
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.