Clinical trial NCT01496547: Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Leukemia
Keywords: feasibility, effective and safety
intensive chemotherapy
RIC regimen
refractory or relapse leukemia
allogeneic stem cell transplantation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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% 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 2-year
Secondary outcomes:
measure: non-relapse mortality
timeFrame: 2-year
measure: relapse rate
timeFrame: 2-year
measure: overall survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiong HU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang W, Fan X, Wang L, Hu J. Busulfan and fludarabine conditioning regimen given at hematological nadir of cytoreduction fludarabine, cytarabine, and idarubicin chemotherapy in patients with refractory acute myeloid leukemia undergoing allogeneic stem cell transplantation: a single arm pilot consort study. Medicine (Baltimore). 2015 Apr;94(15):e706. doi: 10.1097/MD.0000000000000706.