NCT02461121

HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 9 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Detailed description

The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
GENETIC	HLA mismatched stem cell	HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
GENETIC	HLA matched stem cell	HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
DRUG	cyclosporine A	The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
DRUG	Mycophenolate mofetil	The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
DRUG	Ara-C	2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
DRUG	fludarabine	30 mg/m2/d for 5days
DRUG	anti-lymphocyte globulin	1.5-2 mg/kg/d for 4 days
DRUG	cyclophosphamide	40 mg/kg/d for 2 days

Timeline

• Start date: 2004-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2015-06-03
• Last updated: 2015-06-04

Locations

1 site across 1 country: China