UMIN-CTR Clinical Trial

Basic information
Public title	Haploidentical transplantation with post-transplant cyclophosphamide
Acronym	Haploidentical Transplantation (Kurume University PT-CY1)
Scientific Title	Haploidentical transplantation with post-transplant cyclophosphamide
Scientific Title:Acronym	Haploidentical Transplantation (Kurume University PT-CY1)
Region	Japan

Condition
Condition	acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, malignant lymphoma
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 post-transplant cyclophosphamide as GVHD prophylaxis in patients who have no HLA-matched or 7/8 matched, related or unrelated donor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Trasplant-related mortality at day 100
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	GVHD prophylaxis cyclophosphamide 40mg/kg for 2 days tacrolimus 0.02mg/kg/day Mycophenolate Mofetil 750mgx3/day
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. Age: 15-70 years old. 3. 2nd CR or subsequent CR, non CR. 1st CR as defined at least one of the following: a) Acute lymphoblastic leukemia Poor risk as defined by NCCN guidelines b) Acute myelogenous Leukemia Greater than 1 cycle of induction therapy required to achieve remission High risk as defined by NCCN guidelines Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15) Preceding myelodysplastic syndrome c) Myelodysplastic syndrome high, very high as defined by WHO classification-based Prognostic Scoring System Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month. 4. Performance status: 0-2 5. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 6. Patients who have no HLA-matched or 7/8 matched, related donor. 7. Patients who have no HLA-matched or 7/8 matched, related donor. 8. Patients who give written informed consent to participate in the study. 9. Patients who are expected to live for 3 months or more.
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 who are not eligible for this study at the discretion of the investigator.
Target sample size	21

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Koji Nagafuji
Organization	Kurume University School of Medicine
Division name	Division of Hematology & Oncology, Department of Medicine,
Zip code
Address	67 Asahi-machi, Kurume
TEL	0942-31-7852
Email	knagafuji@med.kurume-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Koji Nagafuji
Organization	Kurume University School of Medicine
Division name	Division of Hematology & Oncology, Department of Medicine
Zip code
Address	67 Asahi-machi, Kurume
TEL	0942-31-7852
Homepage URL
Email	knagafuji@med.kurume-u.ac.jp

Sponsor
Institute	Division of Hematology & Oncology, Department of Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Division of Hematology & Oncology, Department of Medicine, Kurume University School of Medicine
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
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	久留米大学医学部　内科学　(血液・腫瘍内科)　講座　(福岡県)

Other administrative information
Date of disclosure of the study information	2015 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	Completed
Date of protocol fixation	2015 Year 08 Month 18 Day
Date of IRB	2015 Year 08 Month 18 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 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	2015 Year 08 Month 19 Day
Last modified on	2019 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021665