Acute Leukemia Clinical Trial
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
Verified date | May 2016 |
Source | Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 particular refractory AML patients.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 30, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - age less than 18 years or over 61 years - liver function/renal function damage (over 2 X upper normal range) - with mental disease |
Country | Name | City | State |
---|---|---|---|
China | Blood & Marrow Transplantation Center, RuiJin Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival | 2-year | ||
Secondary | non-relapse mortality | 2-year | ||
Secondary | relapse rate | 2-year | ||
Secondary | overall survival | 2-year |
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