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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01496547
Other study ID # RJH-2011-RefactoryAML-SCT
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2011
Est. completion date June 30, 2018

Study information

Verified date May 2016
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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% 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.


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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intensive chemo - RIC preparation
The intensive chemotherapy is composed of fludarabine 35mg/m2 + high-dose cytarabine 2g/m2 D1-5 + 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.

Locations

Country Name City State
China Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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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