Trial Title:
the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient
NCT ID:
NCT01766375
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cyclosporine
Mycophenolic Acid
Methotrexate
Cyclosporins
Conditions: Keywords:
idarubicin
busulfan
cyclophosphamide
pretreatment
high-risk acute myeloid leukemia patient
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclosporin A,mycophenolate mofetil,Methotrexate
Description:
GVHD is prevented by CSA+MMF+MTX in sibling allogeneic hematopoietic stem cell
transplantation (starting from day -1, 3mg/kg of CSA was infused by continuous
intravenous drip until gastrointestinal function returned normal when method of
administration was changed to oral administration.
Arm group label:
BUCY
Arm group label:
IDBUCY
Summary:
This study was a multi-center, open, randomized-control study on the effects and safety
of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment
program on the overall survival rate and disease-free survival rate of acute myeloid
leukemia patient in high-risk group over a period of 2 years.
Detailed description:
This study was a multi-center, open, randomized-control study. It evaluates the effects
and safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY
pretreatment program on acute myeloid leukemia patient in high-risk group. 200 patients
were studied with 100 patients in each group.
Patients enrolled were randomly divided into group A (idarubicin 60mg/M2 combined with
BUCY group) and group B (BUCY group). SAS randomization software was used to obtain
randomization numbers. Patients were recommend to start pretreatment within 7 days after
randomization.
Main objective: 2-year overall survival (OS) and disease-free survival (DFS) rates.
Secondary objective: safety evaluation (early complications of transplantation, liver,
kidney and heart toxicity, treatment-related mortality, blood recovery time), the median
period of disease-free survival.
Test drugs Idarubicin (Zavedos ®, Pfizer), busulfan, cyclophosphamide.
Pretreatment plan Drug Group A (IDA 60mg/M2 + BUCY) Group B (BUCY) IDA: 20mg/m2 a day,
d-12 ~d-10, intravenous infusion for 1 hour. BU: 4mg/Kg a day, oral administration, d-7
~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7~d-4.
CY: 60mg/Kg a day, intravenous infusion, d-3~d-2. GVHD prevention plan GVHD is prevented
by CSA+MMF+MTX in sibling allogeneic hematopoietic stem cell transplantation (starting
from day -1, 3mg/kg of CSA was infused by continuous intravenous drip until
gastrointestinal function returned normal when method of administration was changed to
oral administration. 5mg/kg was divided into twice oral intakes, maintaining cyclosporine
concentration at 200-300ug / L; MTX 15mg/m2 at day +1, 10mg/m2 at day +3, +6 and day +11
(based on actual situations day 11 can be omitted); MMF 0.25g BID starting from day 0 and
continued for a month ). Unrelated allogeneic hematopoietic stem cell transplantation
used CSA MMF MTX ATG for the prevention of GVHD. 3mg/kg CSA was infused through
continuous intravenous drip since day -1 until gastrointestinal function returned to
normal when the administration method was changed to oral. 5mg/kg was divided to twice
oral intakes maintaining cyclosporine concentrations at 200-300ug/L; MTX 15mg/m2, at day
+1, 10mg/m2 at day +3, day +6 and day +11 (based on actual situations day 11 can be
omitted); MMF 0.5g BID starting from day 0 and continued for 3 months (a month later,
dose can be reduced according to the hemogram); the total ATG was 6mg/kg and was taken in
three days, from day -4 to day -2.
Relapse intervention Routine preventive DLI is not recommended, however, if tendency of
recurrence found during monitor, chemotherapy, immunotherapy, targeted therapy, secondary
transplantation, etc. can be used, and intervention treatment start time should be
recorded as the end time.
The efficacy evaluation time point
1. 1-3, 6, 12, 18, 24 months after transplantation.
2. Follow-up evaluation: indicators such as blood routines and bone marrow detection,
and minimal residual disease detection after the end of treatment should be done
regularly.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18～50;
2. Received peripheral blood hematopoietic stem cell transplantation from siblings or
unrelated allogeneic donors with identical matching of HLA or 1 alleles mismatched.
3. Diagnosis: refer to 2011 edition of AML China Guideline for the diagnosis and
treatment and diagnosis standards of high-risk acute myeloid leukemia developed
through literatures (see Appendix B);
4. Under general condition, ECOG score ≤ 1;
5. Normal cardiac functions;
6. Normal liver and renal function: blood bilirubin≤35 μ mol\/L, AST/ALT lower than
twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/L;
7. Subjects have signed the informed consent form.
Exclusion Criteria:
1. Severe uncontrolled infection before transplantation;
2. With contraindications of idarubicin;
3. Reached the maximum cumulative dose of anthracyclines, for instance, DNR≥ 450mg/m2,
mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
4. The other conditions that do not meet the inclusion criteria.
Withdrawal criteria:
1. Those do not meet the inclusion criteria or meet the exclusion criteria after
reviewing;
2. Patient withdraws the informed consent form;
3. Patient violates the clinical study protocol;
4. Patient experiences severe adverse events that treatment has to be terminated;
5. Patient that considered no longer fit to complete clinical trials by researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Lai Yongrong, doctor
Phone:
0086-13517711828
Email:
laiyongrong@263.net
Contact backup:
Last name:
Zhang Zhongming, doctor
Phone:
0086-15807801369
Email:
zzmmissyou@126.com
Investigator:
Last name:
Lai Yongrong, doctor
Email:
Principal Investigator
Investigator:
Last name:
Zhang Zhongming, doctor
Email:
Sub-Investigator
Investigator:
Last name:
Li Qiaochuan, doctor
Email:
Sub-Investigator
Start date:
August 2012
Completion date:
June 2016
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01766375
http://www.gxmuyfy.cn/gxmufy1/1fy/index/index.asp
