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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014408
Receipt No. R000016761
Scientific Title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Date of disclosure of the study information 2014/07/27
Last modified on 2018/03/22

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Basic information
Public title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Acronym JSCT-Haplo14 RIC
Scientific Title A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Scientific Title:Acronym JSCT-Haplo14 RIC
Region
Japan

Condition
Condition ALL,AML,MDS,CML,NHL,MM
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 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 Event-free survival at 1 year after transplantation.
Key secondary outcomes 1. Engraftment at 100 days.
2. Non-relapse mortality at 100 days, 1 year and 2 year.
3. Relapse at 100 days, 1 year and 2 year.
4. Event-free survival at 2 year.
5. Overall survival at 1 year and 2 year.
6. Grade 3-4 non-hematologic toxicity within 100 days.
7. Infectious event within 1 year.
8. Acute and Chronic Graft-versus-Host Disease within 2 year.
9. Fever from day 0 to day7.

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
65 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: 15-65 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. Patients who have no prior allogeneic or autologous hematopoietic stem cell transplant
5. Performance status: 0-2
6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
7. Patients who have no HLA-matched or 7/8 matched, related donor.
8. Patients who have no HLA-matched or 7/8 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.
11. 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 62

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Junichi Sugita
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address 060-8638 Sappor
TEL 011-
Email jsct-office@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Junichi Sugita
Organization JSCT
Division name Haplo14 DC
Zip code
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)

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
2014 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 09 Month 27 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016761

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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