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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023235
Receipt No. R000026774
Scientific Title spousal hematopoietic stem cell transplantation for post-transplant relapse/rejection (phase I/II trial)
Date of disclosure of the study information 2016/07/20
Last modified on 2017/02/01

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Basic information
Public title spousal hematopoietic stem cell transplantation for post-transplant relapse/rejection (phase I/II trial)
Acronym spousal hematopoietic stem cell transplantation
Scientific Title spousal hematopoietic stem cell transplantation for post-transplant relapse/rejection (phase I/II trial)
Scientific Title:Acronym spousal hematopoietic stem cell transplantation
Region
Japan

Condition
Condition hematologic malignancies relapesd/rejected after allogeneic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of spousal stem cell transplantation for hematologic malignancies relapsed or rejected after allogeneic transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Rate of donor cell engraftment (defined as Neutrophil >500/microL with >90% of donor origin) on day 35
Key secondary outcomes a) Incidence and severity of chronic GVHD
b) transplantion-associated complications, including TMA
c) survival rate
d) relapse rate
e) other adverse effects (CTCAE)

within three months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The basic structure of the preconditioning regimen consists of fludarabine (FLU) at 30 mg/m2/day for 6 days (days -9 and -4), melphalan (MEL) at 70 mg/ m2/day for 2 days (days -3 and -2), and rabbit anti-thymocyte globulin (ATG, Thymoglobulin, Sanofi) at 1.25 mg/kg/day for 2 days (days -2 and -1). To ensure engraftment, 3 Gy of total body irradiation (TBI) was added. For active diseases, high-dose cytarabine (CA) at 2 g/m2/day for 4 days (days -9 and -6) was added for the purpose of tumor reduction. To prevent anaphylaxis caused by ATG, methylprednisolone (mPSL) was administered at 2 mg/kg on days -2 and -1. GVHD prophylaxis consists of the continuous infusion of TAC with a target concentration of 10-12 ng/mL started from day -3, 1 mg/kg/day of mPSL started after day 0, and 15 mg/kg/day of MMF started from day 3 (Table 1). Peripheral blood stem cells (PBSC) were used as a stem cell source, which were infused without being frozen. G-CSF was administered from day 3 to the day of engraftment.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with hematologic malignancies relapsed or rejected after allogeneic stem cell transplantation who fulfill the following (patient and spousal donor),
[patient]
1) Written informed consent
2) no expectancy of cure with standard therapies including DLI
[spousal donor]
1) healthy spouse who desires to become the donor
2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by the conference)
Key exclusion criteria 1) Cre > 2.0 mg/dl
2) EF < 40%
3) T-Bil > 2.0 mg/dl
4) AST and/or ALT > 200 U/L
5) SpO2 < 90% (room air)
6) PS (ECOG score) 3-4
Patients with data due to original disease are not excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL +81-798-45-6886
Email haplo@hyo-med.a.cjp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Ikegame
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL +81-798-45-6886
Homepage URL
Email kame@hyo-med.a.cjp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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 07 Month 19 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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