Trial Review

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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
Sex
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
8/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
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
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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