NCT01188174

Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

Detailed description

Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure \* Secondary Endpoints: * Feasibility of early transplantation within a multicenter trial * Leukemia-free survival (LFS) at 2 years from transplantation * Leukemia Response rate at day +30, +90 and 6 months * Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM) * Incidence and severity of acute and chronic Graft-versus-Host disease * Feasibility and safety of early discontinuation of immunosuppressive therapy

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Clofarabine	The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-08-25
• Last updated: 2014-12-05

Locations

9 sites across 1 country: France