Back to resultsASCT for Relapsed APL After Molecular Remission
Primary Purpose
Acute Promyelocytic Leukemia, Relapse
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
autologous hematopoietic cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukemia focused on measuring PCR negative
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
Sites / Locations
- Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASCT in relapsed APL
Arm Description
autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
Outcomes
Primary Outcome Measures
disease free survival
Secondary Outcome Measures
overall survival
transplantation related mortality
Full Information
NCT ID
NCT00907582
First Posted
May 21, 2009
Last Updated
December 1, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00907582
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Promyelocytic Leukemia, Relapse
Keywords
PCR negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASCT in relapsed APL
Arm Type
Experimental
Arm Description
autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoietic cell transplantation
Intervention Description
Autologous hematopoietic cell transplantation and condition with the following:
idarubicin 15mg/m2•d day -11 and -10; busulfan 0.8mg/kg•q6h day -6 to -3.
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Title
transplantation related mortality
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIong HU, M.D.
Organizational Affiliation
Shanghai Rui Jin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
ASCT for Relapsed APL After Molecular Remission
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