UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Title of the study (Brief title)	JSCT Haplo16 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 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	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 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 Day -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	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	36

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

Public contact
Name of contact person	Junichi Sugita
Organization	JSCT
Division name	Haplo16 DC
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000023841