Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Public ClinicalTrials.gov record NCT04797767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04797767
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Conditions
- 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
Interventions
- Cladribine Drug
- Cytarabine Drug
- Mitoxantrone Drug
- Recombinant Granulocyte Colony-Stimulating Factor Biological
- Venetoclax Drug
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Biospecimen Collection Procedure
Drug · Biological · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 3, 2022
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2028
- Last update posted
- Apr 16, 2026
2022 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04797767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04797767 live on ClinicalTrials.gov.