UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020655 |
|---|---|
| Receipt number | 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 09:53:47 |
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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-
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
jsct-office@umin.ac.jp
Sponsor or person
Institute
JSCT
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023840
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