NCT01793025

Mismatched Donor Cells to Treat Acute Myeloid Leukemia

Adoptive Transfer of Alloreactive Cells to Treat Patients With Poor-Prognosis Acute Myeloid Leukemia-01

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of infusing immune cells from a donor as treatment for patients with acute myeloid leukemia that is resistant to chemotherapy or who have experienced relapse. Unlike standard bone marrow or stem cell transplantation which uses donors who are well 'matched' to the patient, this study uses donors whose immune cells are not compatible with the patient. With standard stem cell or bone marrow transplantation, the well-matched immune cells will attack the leukemia but they also attack the patient's organs (a situation called graft-versus-host disease, which can persist in the long term). Our hypothesis is that the mismatched donor cells will fight the leukemia but will then be eliminated from the patient's body, so long-term side effects like graft-versus-host disease should not occur.

Detailed description

The ATAC cell therapy product contains unselected, non-mobilized peripheral blood mononuclear cells from related donors who are mismatched to the recipients at 3 or more (out of 6) HLA loci. Cohorts of 3 patients will be treated at each of four pre-specified dose levels (T cells per kg recipient weight). One ATAC infusion is administered 24-48 hours following re-induction chemotherapy (for relapsed or primary refractory AML patients not in remission). In situations where ATAC infusion is not available immediately following re-induction chemotherapy and patients nonetheless achieve complete remission, one ATAC infusion is given 24-48 hours after consolidation chemotherapy.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	ATAC Therapy	Unselected peripheral blood mononuclear cells given 24-48 hours after induction or consolidation chemotherapy

Timeline

• Start date: 2012-09-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2013-02-15
• Last updated: 2017-08-30

Locations

1 site across 1 country: Canada