Clinical trial NCT00907582: ASCT for Relapsed APL After Molecular Remission
Official title: Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Promyelocytic Leukemia
Relapse
Keywords: PCR negative
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: transplantation related mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Shanghai Rui Jin Hospital
name: JIong HU, M.D.
role: PRINCIPAL_INVESTIGATOR
References: