UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026002 |
|---|---|
| Receipt number | R000029893 |
| Scientific Title | A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2026/07/29 10:12:40 |
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Basic information
Public title
A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Acronym
JSCT-Haplo17 RIC
Scientific Title
A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Scientific Title:Acronym
JSCT-Haplo17 RIC
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 the dose reduction and shortening of duration of immunosuppressant after HLA -haploidentical peripheral blood stem cell transplantation using 150mg/m2 of fludarabine, 6.4mg/kg of intravenous busulfan and 4Gy 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
Non-relapse mortality at 180 days
Key secondary outcomes
1. Engraftment at 100 days.
2. The incidence of acute GVHD and chronic GVHD at 180 days, 1 year, and 2 years.
3. Non-relapse mortality at 1 year, and 2 years.
4. The incidence of relapse at 180 days, 1 year, and 2 years.
5. Disease-free survival at 180 days, 1 year, and 2 years.
6. Overall survival at 180 days, 1 year, and 2 years.
7. The incidence of infectious event at 180 days, 1 year, and 2 years.
8. GVHD free, relapse free survival (GRFS) at 180 days, 1 year, and 2 years.
9. The proportion of patients who stopped immunosuppressive drugs within 180 days, 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 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 -4, -3
Total body irradiation (TBI) 4Gy/2fr Day -1
The GVHD prophylaxis regimen will consist of :
Cyclophosphamide 40mg/kg IV days 3, 4
Tacrolimus IV beginning Day 5-90 with dose adjusted to maintain a level of 5-15 ng/ml
Mycophenolate mofetil 15mg/kg po TID beginning Day5-30, 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
| 70 | 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 reduced-intensity conditioning
2. Any disease status
3. Age: 15-70 years old
4. Any prior history of hematopoietic stem cell transplantation
5. Performance status: 0-2
6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
7. Patients who have no HLA-matched related donor.
8. Patients who have no HLA-matched related donor.
9. Patients who are not eligible for allogeneic stem cell transplantation following myeloablative conditioning.
10. Patients who give written informed consent to participate in the study.
Key exclusion criteria
1. Patients who are positive for HBs antigen, HCV antibody, or 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. Positive anti-donor HLA antibody.
7. Patients who need chemotherapy within 13 days before transplantation.
8. Patients whose body mass index is >=30.
9. Patients who are not eligible for this study at the discretion of the investigator.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sugita |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8638
Address
060-8638 Sappor
TEL
011-
jsct-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Sugita |
Organization
JSCT
Division name
Haplo17 DC
Zip code
104-0031
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
a
Address
a
Tel
a
a
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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://hp-jsct.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://hp-jsct.jp/
Number of participants that the trial has enrolled
82
Results
The primary endpoint, the cumulative incidence of non-relapse mortality (NRM) within 180 days after transplantation, was 8.7% (95% CI, 3.8-16.2%), which was below the prespecified threshold of 30%.
Results date posted
| 2026 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sex (male/female): 52/28
Age, median (range), years: 61 (18-70)
Disease: AML 27, ALL 12, MDS 17, malignant lymphoma 16, other 8
Disease status: complete remission 40, other 40
Refined Disease Risk Index: low/intermediate 36, high/very high 44
HCT-CI score: 0-2 66, >=3 14
Participant flow
Between June 2017 and March 2019, a total of 82 patients were enrolled from 40 participating centers. After exclusion of two ineligible patients, 80 patients were included in the analysis.
Adverse events
Serious adverse events requiring expedited reporting included seven deaths within 100 days after transplantation, one death occurring after day 100 that could not be ruled out as related to the protocol treatment, one case of grade 4 elevated serum amylase, two cases of grade 4 renal impairment, and one case of graft failure.
The incidences of major grade 3 or higher adverse events within 30 days after transplantation were oral mucositis (14%), nausea/vomiting (26%), diarrhea (25%), infections (29%), and febrile neutropenia (48%).
Outcome measures
Primary Endpoint
Non-relapse mortality by 180 days after transplantation
Secondary Endpoints
Proportion of patients achieving engraftment by 30 days after transplantation
Incidence and severity of acute and chronic graft-versus-host disease (GVHD) by 180 days, 1 year, and 2 years after transplantation
Non-relapse mortality by 1 year and 2 years after transplantation
Cumulative incidence of relapse by 180 days, 1 year, and 2 years after transplantation
Disease-free survival at 180 days, 1 year, and 2 years after transplantation
Overall survival at 180 days, 1 year, and 2 years after transplantation
Incidence of infections by 180 days, 1 year, and 2 years after transplantation
GVHD-free, relapse-free survival (GRFS) at 180 days, 1 year, and 2 years after transplantation
Proportion of patients who discontinued immunosuppressive therapy at 1 year and 2 years after transplantation
Occurrence and characteristics of fever from the day of transplantation through day 7 after transplantation
Incidence of grade 3 or higher adverse events from the initiation of conditioning therapy through day 100 after transplantation
Subgroup analyses of the above endpoints according to the Disease Risk Index (DRI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029893
