Status:
COMPLETED
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Acute Leukemia
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
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% patien...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- adult patients with refractory or relapse acute myeloid leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
- age 16-60 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6) or unrelated donors (at least 8/10)
Exclusion
- age less than 18 years or over 61 years
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01496547
Start Date
January 1 2011
End Date
June 30 2018
Last Update
March 19 2019
Active Locations (1)
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1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, China, 200025