Brief Title
ASCT for Relapsed APL After Molecular Remission
Official Title
Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
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. Autologous hematopoietic cell transplantation using a polymerase chain reaction (PCR) negative graft is important treatment option to obtain sustainable remission. This study is to test the efficacy and the safety of conditioning regimen with idarubicin and busulfan for relapsed Acute Promyelocytic Leukemia (APL).
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 molecular remission via RT-PCR. Patients received autologous hematopoietic cell transplantation.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
disease free survival
Secondary Outcome
overall survival
Condition
Acute Promyelocytic Leukemia
Intervention
autologous hematopoietic cell transplantation
Study Arms / Comparison Groups
ASCT in relapsed APL
Description: autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
5
Start Date
June 2009
Completion Date
May 2014
Primary Completion Date
May 2014
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
JIong HU, M.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00907582
Organization ID
MHOPES-APL09
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Jiao Tong University School of Medicine
Study Sponsor
JIong HU, M.D., Principal Investigator, Shanghai Rui Jin Hospital
Verification Date
November 2014