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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020655
Receipt No. R000023840
Scientific Title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following myeloablative conditioning
Date of disclosure of the study information 2016/01/20
Last modified on 2017/10/05

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Basic information
Public title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following myeloablative conditioning
Acronym JSCT Haplo16 MAC
Scientific Title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following myeloablative conditioning
Scientific Title:Acronym JSCT Haplo16 MAC
Region
Japan

Condition
Condition hematologic malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of HLA haploidentical peripheral blood stem cell transplantation using 150mg/m2 of fludarabine, 12.8mg/kg of intravenous busulfan and 4Gy of total body irradiation or 90mg/m2 of fludarabine and 12Gy of total body irradiation in patients who have no HLA-matched related or unrelated donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of grade III-IV acute GVHD at 100 days
Key secondary outcomes 1. Engraftment at 100 days.
2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years.
3. Non-relapse mortality at 100 days, 1 year, and 2 years.
4. The incidence of relapse at 100 days, 1 year, and 2 years.
5. Disease-free survival at 100 days, 1 year, and 2 years.
6. Overall survival at 100 days, 1 year, and 2 years.
7. The incidence of infectious event at 100 days, 1 year, and 2 years.
8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years.
9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year.
10. Noninfectious fever within 7 days after transplantation
11. Grade 3-4 non-hematologic toxicity within 100 days.
12. Subgroup analysis subgroup analysis according to conditioning regimen.
13. Subgroup analysis subgroup analysis according to disease risk index (DRI)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The preparative regimen will consist of :
Fludarabine 30mg/m2 IV Days -6, -5, -4, -3, -2
Busulfan 3.2mg/kg IV Days -6, -5, -4, -3
Total body irradiation (TBI) 4Gy Day -1
or
Fludarabine 30mg/m2 IV Days -6, -5, -4
TBI 12Gy Day -3, -2, -1

The GVHD prophylaxis regimen will consist of :
Cyclophosphamide 50mg/kg IV days 3, 4
Tacrolimus IV beginning Day 5 with dose adjusted to maintain a level of 5-15 ng/ml
Mycophenolate mofetil 15mg/kg po TID beginning Day5, maximum dose 1 g po TID.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation following myeloablative conditioning
2. Any disease status
3. Age: 15-60 years old
4. Performance status: 0-2
5. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
6. Patients who have no HLA-matched related donor.
7. Patients who have no HLA-matched related donor.
8. Patients who give written informed consent to participate in the study.
Key exclusion criteria 1. Patients who are positive for HIV antibody.
2. Patients with active other malignancies.
3. Patients with active infectious disease.
4. Women who are pregnant, of childbearing potential, or lactating.
5. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, fludarabine, tacrolimus, mycophenolate mofetil.
6. Patients who has a prior history of allogeneic transplantation.
7. Positive anti-donor HLA antibody.
8. Patients who need chemotherapy within 13 days before transplantation.
9. Patients who are not eligible for this study at the discretion of the investigator.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Sugita
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address 060-8638 Sappor
TEL 011-
Email jsct-office@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Sugita
Organization JSCT
Division name Haplo16 DC
Zip code
Address 104-0031
TEL 03-6225-2025
Homepage URL
Email jsct-office@umin.ac.jp

Sponsor
Institute JSCT
Institute
Department

Funding Source
Organization Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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