Neoplasms

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Sarcoma

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Sarcoma, Myeloid

Leukemia, Biphenotypic, Acute

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Neoplasms, Connective and Soft Tissue

Disease Attributes

Leukemia, Lymphoid

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Soft Tissue Sarcoma

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Leukemia of Ambiguous Lineage

Myeloid Sarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Cytarabine

Venetoclax

Mitoxantrone

Lenograstim

Cladribine

2-chloro-3'-deoxyadenosine

2'-deoxyadenosine

Cordycepin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Adjuvants, Immunologic

Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive venetoclax orally (PO) on days 1-14. Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone, and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity.

Recombinant Granulocyte Colony-Stimulating Factor

Mary-Beth M. Percival

This phase I trial finds the best dose and side effects of 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.

OUTLINE:

This is a dose-escalation study of venetoclax.

Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive venetoclax orally (PO) on days 1-14. Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone, and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 12 months.

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

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

AbbVie

University of Washington

Spots Global Cancer Trial Database for refractory myeloid neoplasm