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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082595
ACTR Number: ACTRN12608000129381
Trial Status: Registered
Date Submitted: 11/02/2008
Date Registered: 13/03/2008

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Public title: Cotransplantation of mesenchymal stem cells with nonmyeloablative haploidentical peripheral blood stem cells without T cells deleted for high-risk acute leukemia: to reduce the severity of graft versus host disease and relapse
ANZCTR registration title: Cotransplantation of mesenchymal stem cells with nonmyeloablative haploidentical peripheral blood stem cells without T cells deleted for high-risk acute leukemia: to reduce the severity of graft versus host disease and relapse
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
High-risk acute leukemia patients 
Condition category: Condition code:
Cancer Leukaemia - Acute leukaemia 

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Description of intervention(s) / exposure: It consisted of fludarabine 30mg/m2/day (days –6 to -2), total body irradiation (60Co) 2Gy(day -1), cyclophosphamide (CTX) 40 mg/kg/day (days -4, -2), Ara-C (cytarabine) 1.5~2.0 g/m2 (days -6 to -3), and rabbit anti-human thymocyte globulin (ATG, France) 1.5~2.0 mg/kg/d (days -4 to -1). mesenchymal stem cells administrated by Intra-bone Marrow injection into iliac bones 30 min before hematopoietic stem cells infusion at day 0.
Intervention code 1:Treatment: Other 
Intervention code 2:Treatment: drugs 
Comparator / control treatment: It consisted of fludarabine 30mg/m2/d (days –6 to -2), total body irradiation (60Co) 2Gy(day -1), cyclophosphamide (CTX) 40 mg/kg/day (days -4, -2), Ara-C (cytarabine) 1.5~2.0 g/m2 (days -6 to -3), and rabbit anti-human thymocyte globulin (ATG, France) 1.5~2.0 mg/kg/day (days -4 to -1). hematopoietic stem cells infused without mesenchymal stem cells co-transplantation on day 0.
Control group: Placebo

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Primary outcome 1:Transplant ralated mortality, include conditioning complication and severe infection 
Timepoint:1 year 
Primary outcome 2:Incidence of graft-versus-host disease,include acute and chronic GVHD 
Timepoint:1 year 
Primary outcome 3:Survival 
Timepoint:1 year 
Secondary outcome 1:Overall survival:from treatment begining to search time point 
Timepoint:3 years 
Secondary outcome 2:Leukemia relapse rates 
Timepoint:3 years 

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Key inclusion criteria: High risk leukemia patients
Minimum Age: 9 Years
Maximum Age: 60 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: The patients with blast cells is over 50% in bone marrow after chemotherapy

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 2
Anticipated or actual date of first participant enrolement: 8/03/2008
Target sample size: 40
Recruitment status: Open to recruitment

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Funding source:Hospital 
Name:Affiliated Hospital of Academy of Military Medicine Science 
Address:Dongdajie Road 8 Beijing 
Country:China 
Primary sponsor: Individual
Name: Huisheng Ai
Address: Affiliated Hospital of Academy of Military Medicine Science Dongdajie Road 8 Beijing
Country: China
Secondary sponsor:Hospital 
Name:Affiliated Hospital of Academy of Military Medicine Science 
Address:Affiliated Hospital of Academy of Military Medicine Science Dongdajie Road 8 Beijing 
Country:China 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Ethics Committee of Affiliated Hospital of Academy of Military Medicine Science 
Address: 
Country:China 
Date of approval:1/01/2007 
HREC Number:2007-SCT 
Countries of recruitment:Outside Australia 
China - Beijing 
Brief summary: Background: Severe graft-versus-host disease (GVHD) and graft rejection are still major complications of haploidentical stem cell transplantation, especially for haploidentical nonmyeloablative transplantation (Haploidentical-NST). Many data have shown that bone marrow–derived mesenchymal stem cells (MSCs) have some immunosuppressive capability and enhancing hematopoietic engraftment. Based on our previous researches on the phase I clinical trial of MSCs in humans and experiment of monkeys rhesus model, we designed a new strategy that included cotransplantation of MSCs with Haploidentical-NST, in order to improve the effectiveness of haploidentical transplantation in high-risk acute leukemia patients.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Kaixun Hu
Address: Department of Hematology
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country: China
Tel: +86 01066947129
Fax: +86 01066947120
Email: hukaixun@sohu.com

Contact person for scientific queries
Name: Huisheng Ai
Address: Department of Hematology
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country: China
Tel: +86 01066947126
Fax: +86 01066947120
Email: aihuisheng@sohu.com

Contact person responsible for updating information
Name: Huisheng Ai
Address: Department of Hematology
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country: China
Tel: +86 01066947129
Fax: +86 01066947120
Email: hukaixun@sohu.com
   
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