UMIN-CTR Clinical Trial

Basic information
Public title	Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1)
Acronym	PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor (OCU16-1)
Scientific Title	Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1)
Scientific Title:Acronym	PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor (OCU16-1)
Region	Japan

Condition
Condition	Acute myeloid leukemia(AML) Acute lymphoblastic leukemia(ALL) Acute leukemias of ambiguous lineage Myelodysplastic syndrome(MDS) Chronic myeloid leukemia(CML) Malignant lymphoma(ML)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation for safety and efficacy of PTCy and Tac for GVHD prevention of allo-HCT from HLA matched donor in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1 year chronic GVHD cumulative incidence
Key secondary outcomes

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	Cy is intravenously administered at 50mg/kg/day on days 3 and 4. Continuous intravenous infusion of Tac is started at 0.03mg/kg/day from day 5. Unless GVHD developed, Tac was tapered from day 60-100 and stopped until day 180.
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) Disease (a) AML (b) ALL (c) Acute leukemias of ambiguous lineage (d) MDS 1. IPSS int-2 or high 2. Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion) (e) CML 1. CP beyond 1st CP 2. TKI failure in 1st CP (f) malignant lymphoma 1. Indolent lymphoma after 1st relapse/progression 2. Aggressive lymphoma *Chemo-refractory lymphoma after 1st relapse, or *Lymphoma after 2nd relapse, or *relapsed Lymphoma after auto-HCT (g) a rare hematological malignancy except for (a)~(f) that was judged as necessity of allo-HCT in our conference (2) Age >=15 and < 70 years old (3) ECOG PS 0 or 1 (4) Normal function of major organs (5) donor: presence of available sibling or unrelated donor with HLA-A, B, C, and DRB1 allele 8/8 match in GVH direction (Note: no limitation for conditioning regimen intensity)
Key exclusion criteria	1) Major organ dysfunction a) Total bilirubin:>= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia 7) Pregnant, lactating or possible fertile women who may become pregnant 8) Patients with a severe mental who are likely to be unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 10) HIV antibody positivity 11) The administration of ATG is scheduled in conditioning regimen. 12) The physician in charge determines that there is no indication to perform this intervention. (Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)
Target sample size	39

Research contact person
Name of lead principal investigator	1st name Hirohisa Middle name Last name Nakamae
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan, 545-8585
TEL	06-6645-3881
Email	hirohisa@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Hirohisa Middle name Last name Nakamae
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan, 545-8585
TEL	06-6645-3881
Homepage URL
Email	crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka City University Hospital Certified Review Board
Address	1-2-7, Asahi-machi, Abeno-ku, Osaka, Japan, 545-0051
Tel	06-6645-3456
Email	irb@med.osaka-cu.ac.jp

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 09 Month 01 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 07 Month 01 Day
Date of IRB	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 20 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 01 Day
Last modified on	2020 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025803