Sequential Intensive Chemotherapy Followed by Reduce-intensity Conditioning for Refractory and Relapse Acute Myeloid Leukemia
Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this study, we focus on a new treatment strategy for this particular high-risk patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sequential Intensive Chemotherapy Followed by Allogeneic Stem Cell Transplantation With Reduce-intensity Conditioning for Refractory and Relapse Acute Myeloid Leukemia in Adult Patients|
- overall survival [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
- non-relapse mortality [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
- relapse rate [ Time Frame: 2-year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: intensive chemo - RIC preparation
The intensive chemotherapy is composed of Fludarabine 35mg/m2 D1-5, high-dose cytarabine 2g/m2 D1-5 + Mitoxantrone (10mg/m2) or idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 7 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
Drug: intensive chemo - RIC preparation
The intensive chemotherapy is composed of fludarabine 35mg/m2 + high-dose cytarabine 2g/m2 D1-5 + Mitoxantrone (10mg/m2) or idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 10 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
This is a single arm phase II trial to test the efficacy and feasibility of new sequential intensive chemo and transplantation approach for refractory leukemia. Patients with refractory acute myeloid or lymphoblastic leukemia are enrolled in this trial. Patients will received intensive chemotherapy including Fludarabine, cytarabine and idarubicin as (FLAG-IDA). Seven days after the chemotherapy, sequential transplantation conditioning regimen as fludarabine and busulfan will be given.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496547
|Contact: Jiong HU, M.D.||email@example.com|
|Blood & Marrow Transplantation Center, RuiJin Hospital||Recruiting|
|Shanghai, China, 200025|
|Contact: Jiong HU, M.D.|
|Principal Investigator: Ling Wang, M.D.|
|Principal Investigator:||Jiong HU, M.D.||Shanghai Jiao Tong University School of Medicine|