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the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient (IDBUCY)

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ClinicalTrials.gov Identifier: NCT01766375
Recruitment Status : Unknown
Verified January 2013 by Lan YongRong, Guangxi Medical University.
Recruitment status was:  Recruiting
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
Sponsor:
Information provided by (Responsible Party):
Lan YongRong, Guangxi Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Cyclosporin A,mycophenolate mofetil,Methotrexate Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open, Randomized-control Study to Compare the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient
Study Start Date : August 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDBUCY

Idarubicin: 20mg/m2 a day, d-12 ~d-10, intravenous infusion for 1 hour. Busulfan: 4mg/Kg a day, oral administration, d-7 ~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7~d-4.

cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3~d-2.

 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.
Active Comparator: BUCY

Busulfan: 4mg/Kg a day, oral administration, d-7 ~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7~d-4.

Cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3~d-2.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. 2-year disease-free survival (DFS) rates [ Time Frame: 4 years ]
    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.


Secondary Outcome Measures :
  1. 2-year overall survival (OS) rates [ Time Frame: 4 years ]
    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


Other Outcome Measures:
  1. safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program [ Time Frame: 4 years ]
    safety evaluation (early complications of transplantation, liver, kidney and heart toxicity, treatment-related mortality, blood recovery time),


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766375


Contacts
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Contact: Lai Yongrong, doctor 0086-13517711828 laiyongrong@263.net
Contact: Li Qiaochuan, doctor 0086-13768411929 liqiaochuan@sohu.com

Locations
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China, Guangxi
First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Lai Yongrong, doctor    0086-13517711828    laiyongrong@263.net   
Contact: Zhang Zhongming, doctor    0086-15807801369    zzmmissyou@126.com   
Principal Investigator: Lai Yongrong, doctor         
Sub-Investigator: Zhang Zhongming, doctor         
Sub-Investigator: Li Qiaochuan, doctor         
Sponsors and Collaborators
Guangxi Medical University
More Information
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Additional Information:

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Responsible Party: Lan YongRong, Director of the Hematology department of the First Affiliated Hospital of Guangxi Medical University, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT01766375    
Other Study ID Numbers: GuangXi-AML- HSCT-2012-07
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013
Keywords provided by Lan YongRong, Guangxi Medical University:
idarubicin
busulfan
cyclophosphamide
pretreatment
high-risk acute myeloid leukemia patient
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclosporine
Mycophenolic Acid
Methotrexate
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents