Status:
TERMINATED
ASCT for Relapsed APL After Molecular Remission
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Acute Promyelocytic Leukemia
Relapse
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of mylotarg. Autol...
Detailed Description
Once relapsed acute promyelocytic leukemia achieved molecular remission after all-trans retinoic acid (ATRA) and arsenic treatment, PBSC was mobilized and collected with further confirmation of molecu...
Eligibility Criteria
Inclusion
- Men or women between age 18-60 years old
- Acute promyelocytic leukemia after relapse with confirmed cytogenetics t(15;17) and molecular analysis (PML-RARalpha)
- Mobilized peripheral CD34+ over 2x106/kg with negative PML-RAR alpha confirmed by PCR
- European Cooperative Oncology Group performance status 0-3
- Serum bilirubin \< 1.5x the upper limit of normal (ULN)
- Serum alanine transaminase (ALT)/aspartate transaminase values \< 2.5 x ULN
- Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study
Exclusion
- Woman of child bearing potential
- Serum creatinine \> 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
- Known allergy to idarubicin
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00907582
Start Date
June 1 2009
End Date
May 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China, 200025