NCT02587871

Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission

HLA-Mismatched Allogeneic Cellular Therapy (Microtransplantation) After Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia < 60 Years

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 59 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well donor cellular therapy after cytarabine works in treating patients with intermediate-risk acute myeloid leukemia with a decrease in or disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term transfusion of cells from a family member who is incompletely matched. The use of these partially matched white blood cells may help improve response to standard chemotherapy (cytarabine) and reduce some of the risks of infection, without a permanent transplant. Drugs used in chemotherapy, such as cytarabine, 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 donor cellular therapy after cytarabine may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess 2-year disease-free survival (as defined by time to death from any cause or disease relapse, whichever is earlier) for patients \< 60 years of age with intermediate-risk acute myeloid leukemia (AML), in complete remission (CR) after induction chemotherapy, who receive microtransplantation, compared to patients who received consolidation chemotherapy only in a historical published comparable cohort of patients. SECONDARY OBJECTIVES: I. To obtain estimates of rate of relapse, treatment related mortality (TRM), all cause mortality, in the microtransplantation (MST) group and compare it with allogeneic stem cell group (historical cohort). II. To obtain estimates of rate acute graft-versus-host disease (GVHD), chronic GVHD, time to recovery of absolute neutrophil counts and platelets in patients with intermediate risk AML receiving of chemotherapy in combination with microtransplantation. TERTIARY OBJECTIVES: I. Presence or absence of detectable donor chimerism post-microtransplantation until 6 months after the last infusion. II. Characteristics of the infused cells and composition of the graft. III. Dynamics of T-cell clonality. IV. Immune cell subset analysis. OUTLINE: Approximately 4-6 weeks after completion of induction chemotherapy, patients receive cytarabine intravenously (IV) over 1-3 hours twice daily (BID) on days -7 to -2 and granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood cells (microtransplant) IV over 15-20 minutes on day 0. Treatment repeats every 8-10 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at least every 3 months for 2 years.

Conditions

• Adult Acute Myeloid Leukemia in Remission
• Childhood Acute Myeloid Leukemia in Remission

Interventions

Type	Name	Description
DRUG	Cytarabine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo microtransplant
BIOLOGICAL	Therapeutic Allogeneic Lymphocytes	Undergo microtransplant
BIOLOGICAL	G-CSF mobilized peripheral blood cells	microtransplantation

Timeline

• Start date: 2018-12-12
• Primary completion: 2020-11-12
• Completion: 2022-11-12
• First posted: 2015-10-27
• Last updated: 2018-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study