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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01766375
Other study ID # GuangXi-AML- HSCT-2012-07
Secondary ID
Status Recruiting
Phase Phase 3
First received December 28, 2012
Last updated January 9, 2013
Start date August 2012
Est. completion date June 2016

Study information

Verified date January 2013
Source Guangxi Medical University
Contact Lai Yongrong, doctor
Phone 0086-13517711828
Email laiyongrong@263.net
Is FDA regulated No
Health authority China:The First Affiliated Hospital of Guangxi Medical UniversityChina:Shanghai Ruijin HospitalChina:Guangdong Provincial People's HospitalChina:Wuhan Tongji HospitalChina:Yunnan Military HospitalChina:The First People's Hospital of ShanghaiChina:The First Affiliated Hospital of Chongqing Medical UniversityChina:Affiliated Hospital of Guiyang Medical CollegeChina:The First Affiliated Hospital of Xinjiang Medical CollegeChina:The First People's Hospital of Yunnan ProvinceChina:The First Affiliated Hospital of Anhui Medical UniversityChina:Tang Du Hospital of Fourth Military Medical UniversityChina:The First Affiliated Hospital of Nanchang UniversityChina:Henan Cancer Hospital
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Cyclosporin A,mycophenolate mofetil,Methotrexate
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.

Locations

Country Name City State
China First Affiliated Hospital of Guangxi Medical University Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program safety evaluation (early complications of transplantation, liver, kidney and heart toxicity, treatment-related mortality, blood recovery time), 4 years Yes
Primary 2-year disease-free survival (DFS) rates The purpose of this study is to evaluates the effects of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on acute myeloid leukemia patient in high-risk group. 4 years No
Secondary 2-year overall survival (OS) rates It evaluates the effects 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 4 years No
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