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Trial registered on ANZCTR


Registration number
ACTRN12608000129381
Ethics application status
Approved
Date submitted
11/02/2008
Date registered
13/03/2008
Date last updated
13/03/2008
Type of registration
Retrospectively registered

Titles & IDs
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
Scientific 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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-risk acute leukemia patients 2814 0
Condition category
Condition code
Cancer 2950 2950 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
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] 2551 0
Treatment: Other
Intervention code [2] 2646 0
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

Outcomes
Primary outcome [1] 3831 0
Transplant ralated mortality, include conditioning complication and severe infection
Timepoint [1] 3831 0
1 year
Primary outcome [2] 3933 0
Incidence of graft-versus-host disease,include acute and chronic GVHD
Timepoint [2] 3933 0
1 year
Primary outcome [3] 3934 0
Survival
Timepoint [3] 3934 0
1 year
Secondary outcome [1] 6459 0
Overall survival:from treatment begining to search time point
Timepoint [1] 6459 0
3 years
Secondary outcome [2] 6614 0
Leukemia relapse rates
Timepoint [2] 6614 0
3 years

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 785 0
China
State/province [1] 785 0
Beijing

Funding & Sponsors
Funding source category [1] 3077 0
Hospital
Name [1] 3077 0
Affiliated Hospital of Academy of Military Medicine Science
Address [1] 3077 0
Dongdajie Road 8
Beijing
Country [1] 3077 0
China
Primary sponsor type
Individual
Name
Huisheng Ai
Address
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country
China
Secondary sponsor category [1] 2771 0
Hospital
Name [1] 2771 0
Affiliated Hospital of Academy of Military Medicine Science
Address [1] 2771 0
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country [1] 2771 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5025 0
Ethics Committee of Affiliated Hospital of Academy of Military Medicine Science
Ethics committee address [1] 5025 0
Ethics committee country [1] 5025 0
China
Date submitted for ethics approval [1] 5025 0
01/06/2005
Approval date [1] 5025 0
01/01/2007
Ethics approval number [1] 5025 0
2007-SCT

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28364 0
Address 28364 0
Country 28364 0
Phone 28364 0
Fax 28364 0
Email 28364 0
Contact person for public queries
Name 11521 0
Kaixun Hu
Address 11521 0
Department of Hematology
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country 11521 0
China
Phone 11521 0
+86 01066947129
Fax 11521 0
+86 01066947120
Email 11521 0
hukaixun@sohu.com
Contact person for scientific queries
Name 2449 0
Huisheng Ai
Address 2449 0
Department of Hematology
Affiliated Hospital of Academy of Military Medicine Science
Dongdajie Road 8
Beijing
Country 2449 0
China
Phone 2449 0
+86 01066947126
Fax 2449 0
+86 01066947120
Email 2449 0
aihuisheng@sohu.com

No information has been provided regarding IPD availability
Summary results
No Results