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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010316
Receipt No. R000012076
Scientific Title A Phase II trial of haploidentical transplantation with high dose, post-transplantation cyclophosphamide.
Date of disclosure of the study information 2013/03/26
Last modified on 2018/03/21

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Basic information
Public title A Phase II trial of haploidentical transplantation with high dose, post-transplantation cyclophosphamide.
Acronym JSCT-Haplo13
Scientific Title A Phase II trial of haploidentical transplantation with high dose, post-transplantation cyclophosphamide.
Scientific Title:Acronym JSCT-Haplo13
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 The objective of this study is to assess the efficacy and safety of haploidentical transplantation with high dose, post-transplantation cyclophosphamide in patients who have no HLA-matched or 7/8 matched, related or unrelated donor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transplant-related mortality at 100 days.
Key secondary outcomes 1. Overall survival, progression-free survival, relapse at 100 days.
2. Overall survival, progression-free survival, Relapse, Transplant-related mortality at 1 year.
3. Neutrophil and platelet recovery.
4. Graft failure.
5. Full donor chimerism.
6. Acute Graft-versus-Host Disease.
7. Chronic Graft-versus-Host Disease.
8. Infection
9. Grade 3-4 non-hematologic toxicity within 100 days.

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
Cyclophosphamide 14.5mg/kg IV Days -6, -5
Busulfan 3.2mg/kg IV Days -3, -2
Total body irradiation (TBI) 2Gy Day -1
Day 0 will be the day of infusion of non-T-cell depleted peripheral blood stem cells

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
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.
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 prior allogeneic or autologous hematopoietic stem cell transplant are not excluded.
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 give written informed consent to participate in the study.
10. 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 20

Research contact person
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 011-706-7214
Email sugita@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name JSCT
Organization JSCT
Division name Haplo13 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
2013 Year 03 Month 26 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 Allogeneic hematopoietic stem cell transplantation (allo-SCT) using post-transplant cyclophosphamide (PTCy) is increasingly performed. We conducted a multicenter phase II study to evaluate the safety and efficacy of PTCy-based HLA-haploidentical peripheral blood stem cell transplantation (PTCy-haploPBSCT) after busulfan-containing reduced-intensity conditioning. Thirty-one patients were enrolled; 61% patients were not in remission and 42% patients had a history of prior allo-SCT. Neutrophil engraftment was achieved in 87% patients with a median of 19 days. The cumulative incidence of grades II to IV and III to IV acute graft-versushost disease (GVHD) and chronic GVHD at 1 year were 23%, 3%, and 15%, respectively. No patients developed severe chronic GVHD. Day 100 nonrelapse mortality (NRM) rate was 19.4%. Overall survival, relapse, and disease-free survival rates were 45%, 45%, and 34%, respectively, at 1 year. Subgroup analysis showed that patients who had a history of prior allo-SCT had lower engraftment, higher NRM, and lower overall survival than those not receiving a prior allo-SCT. Our results suggest that PTCy-haploPBSCT after busulfan-containing reduced-intensity conditioning achieved low incidences of acute and chronic GVHD and NRM and stable donor engraftment and low NRM, particularly in patients without a history of prior allo-SCT.
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
2013 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 05 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
2013 Year 03 Month 26 Day
Last modified on
2018 Year 03 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012076

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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