Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2029-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective phase II clinical study to be conducted at the Medical College of Wisconsin. After meeting the study criteria and enrollment, patients will be treated with Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) chemotherapy and followed at periodic intervals to determine the primary and secondary objectives.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Cladribine; Cytarabine; Mitoxantrone

Criteria

Inclusion Criteria:

1. Age ≥18 years at the time of informed consent.

2. Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS) or therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria.

3. Patients must meet one of the following criteria:

• In first or subsequent relapse or refractory status, with or without prior hematopoietic stem cell transplant (HSCT) OR

• Patients with MDS transformed to AML will be eligible even if they had not received prior therapy for AML.

4. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.

5. Patients must meet the following clinical laboratory criteria: Direct bilirubin ≤ 1.5 X the upper limit of the normal range (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN unless related to AML or Gilbert syndrome or hemolysis. Calculated creatinine clearance ≥30 mL/min

6. Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

1. Acute Promyelocytic Leukemia.

2. Pregnant or breast feeding women.

3. Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.