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

NCT01766375 | Unknown Phase 3

• 1 other identifier: GuangXi-AML- HSCT-2012-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

idarubicin; busulfan; cyclophosphamide; pretreatment; high-risk acute myeloid leukemia patient

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 2-year overall survival (OS) rates

  4 years

Other Outcomes (1)

• safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program

  4 years

Study Arms (2)

IDBUCY

EXPERIMENTAL

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

BUCY

ACTIVE COMPARATOR

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

Interventions

Cyclosporin A,mycophenolate mofetil,Methotrexate DRUG

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.

BUCY; IDBUCY

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18～50;
• Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of HLA or 1 alleles mismatched.
• 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);
• Under general condition, ECOG score ≤ 1;
• Normal cardiac functions;
• 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;
• Subjects have signed the informed consent form.

You may not qualify if:

• Severe uncontrolled infection before transplantation;
• With contraindications of idarubicin;
• Reached the maximum cumulative dose of anthracyclines, for instance, DNR≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
• Withdrawal criteria:
• Patient withdraws the informed consent form;
• Patient violates the clinical study protocol;
• Patient experiences severe adverse events that treatment has to be terminated;
• Patient that considered no longer fit to complete clinical trials by researchers.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Lai Yongrong, doctor

CONTACT

0086-13517711828; laiyongrong@263.net

Li Qiaochuan, doctor

CONTACT

0086-13768411929; liqiaochuan@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Hematology department of the First Affiliated Hospital of Guangxi Medical University

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 11, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

CN (1)