Phase II Study of CLAG-GO Chemotherapy for Adults with Persistent, Relapsed, or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating a combination of chemotherapy drugs called CLAG-GO, which includes cladribine, cytarabine, granulocyte-colony stimulating factor G-CSF, and gemtuzumab ozogamicin GO, in adults with acute myeloid leukemia AML that has not responded to standard therapy or has returned after remission. This phase II trial focuses on patients with persistent or relapsed AML to assess the treatments safety and effectiveness, conducted at the University of Maryland Greenebaum Comprehensive Cancer Center. Participants will first undergo screening to confirm eligibility. Those eligible will be hospitalized for 4 to 5 weeks to receive induction chemotherapy with the CLAG-GO regimen, involving specific doses of G-CSF, cladribine, cytarabine, and gemtuzumab ozogamicin on scheduled days. If remission is achieved, participants may receive consolidation chemotherapy using the same drugs or proceed to bone marrowstem cell transplantation. Patients remaining in remission after consolidation may continue with up to eight outpatient maintenance cycles of gemtuzumab ozogamicin every 28 days. Throughout the study, participants will have lab tests, exams, and special studies to monitor treatment effects, side effects, and how well the drugs work. Researchers will assess response rates, treatment-emergent adverse events, minimal residual disease, and overall survival. Monitoring includes bone marrow samples and genetic analyses. The total study duration may extend up to two years for outcome assessments, with continuous safety and treatment response evaluations.

CLAG-GO for Patients With Persistent, Relapsed or Refractory AML