Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
ASCT for Relapsed APL After Molecular Remission
Sponsors
Source
Shanghai Jiao Tong University School of Medicine
Oversight Info
Has Dmc
No
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.
Overall Status
Terminated
Start Date
2009-06-01
Completion Date
2014-05-01
Primary Completion Date
2014-05-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
disease free survival |
3 years |
Secondary Outcome
Measure |
Time Frame |
|
overall survival |
3 years |
|
transplantation related mortality |
3 years |
Enrollment
5
Conditions
Intervention
Intervention Type
Procedure
Intervention Name
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.
Arm Group Label
ASCT in relapsed APL
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
Minimum Age
18 Years
Maximum Age
60 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
JIong HU, M.D. |
Principal Investigator |
Shanghai Rui Jin Hospital |
Location
Facility |
|
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine Shanghai 200025 China |
Location Countries
Country
China
Verification Date
2014-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Shanghai Jiao Tong University School of Medicine
Investigator Full Name
Jiong HU
Investigator Title
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Idarubicin
Arm Group
Arm Group Label
ASCT in relapsed APL
Arm Group Type
Experimental
Description
autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
Firstreceived Results Date
N/A
Why Stopped
slow recruitment
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
May 21, 2009
Study First Submitted Qc
May 21, 2009
Study First Posted
May 22, 2009
Last Update Submitted
December 1, 2014
Last Update Submitted Qc
December 1, 2014
Last Update Posted
December 2, 2014
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.