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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026028
Receipt No. R000029711
Scientific Title Allogeneic hematopoietic stem cell transplantation (HSCT) from HLA-haploidentical related donor using reduced dose of posttransplantation high-dose cyclophosphamide (PTCy) for poor prognosis or refractory hematological malignancies (OCU16-2)
Date of disclosure of the study information 2017/02/08
Last modified on 2017/02/07

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Basic information
Public title Allogeneic hematopoietic stem cell transplantation (HSCT) from HLA-haploidentical related donor using reduced dose of posttransplantation high-dose cyclophosphamide (PTCy) for poor prognosis or refractory hematological malignancies (OCU16-2)
Acronym HLA-haploidentical HSCT with reduced dose of PTCy (OCU16-2)
Scientific Title Allogeneic hematopoietic stem cell transplantation (HSCT) from HLA-haploidentical related donor using reduced dose of posttransplantation high-dose cyclophosphamide (PTCy) for poor prognosis or refractory hematological malignancies (OCU16-2)
Scientific Title:Acronym HLA-haploidentical HSCT with reduced dose of PTCy (OCU16-2)
Region
Japan

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

Objectives
Narrative objectives1 To assess the safety and efficacy of HLA-haploidentical allogeneic stem cell transplantation using reduced dose of posttransplantation cyclophosphamide from related donor for patients with poor-prognosis or refractory hematological malignancy who lack an HLA serological identical related donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients who survive with graft engraftment at 100 days fo1lowing transplantation
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fludarabine (15 mg/square meter of body surface area twice a day for 2 days and 30 mg/square meter once a day for 4 days), cytarabine (2 g/square meter twice a day for 2 days), and melphalan (100 mg/ square meter per day for 1 day) are used as a conditioning regimen. Cyclophosphamide 50 mg/kg is given on day 3, 25 mg/kg on day 4 after the graft infusion. The donor source is peripheral blood stem cell. Continuous intravenous tacrolimus (0.03 mg/kg/day) and oral mycophenolate mofetil 1,000 mg three times a day are initiated from day 5 after transplantation.
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 Among patients with refractory hematological disorders (indicated in the selection criteria) who are clinically adopted to allo-HSCT because they cannot expect to be cured or long-term survival by any other therapy, patients who do not have or not available HLA serological identical related donors and have HLA-haploidentical donors.

1) Age >= 15 and < 70 years old
2) ECOG PS 0 or 1
3) Normal function of major organs
4) Informed consent has been acquired
5)Indication
(a) AML
1. Refractory to 1st induction therapy
2. Relapse after chemotherapy
3. Unfavorable chromosome abnormality including del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q, 17q, t(6;9), t(9;22) or complex karyotype
4. Normal karyotype and FLT3-ITD mutation
5. Intermediate/poor group by JALSG score
6. AML with MRC
7. History of relapse after allo-HSCT
8. CR1 with standard risk or high risk
(b) ALL
1. Refractory to 1st induction therapy
2. Relapse after chemotherapy
3. Any of the following poor prognostic factors
i) t(9;22) or t(4;11)
ii) >= 35 years of age at diagnosis
iii) WBC count of more than 30,000/uL for B-ALL, or more than 100,000/uL for T-ALL at diagnosis
4. History of relapse after allo-HSCT
(c) Acute leukemias of ambiguous lineage
1. Refractory to the first induction therapy
2. Relapse after chemotherapy
3. Unfavorable chromosome abnormality
4. History of relapse after allo-HSCT
(d) MDS
1. RAEB-1 or 2
2. IPSS intermediate-2 or high
3. Transfusion dependent
4. History of relapse after allo-HSCT
(e) CML
1. AP or BC: refractory to multiple TKIs
2. CP beyond 1st CP or AP
3. History of relapse after allo-HSCT
(f) ATLL, ML
1. ATLL
Acute or lymphoma type in the PR or better
2. ML
Malignant lymphoma which is classified in the 2008 WHO classification which relapse after auto-HSCT, or which have no indication for auto-HSCT due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy
Key exclusion criteria 1) Major organ dysfunction
a) Total bilirubin: >= 2.0 mg/dl
b) Serum creatinine: >= 2.0 mg/dl
c) Left ventricular 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, coronary failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia
7) Pregnant, lactating woman or woman of childbearing potential
8) Patients with a severe mental disorder 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) A history of administration of mogamulizumab
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 33

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

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 08 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
2017 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 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
2017 Year 02 Month 07 Day
Last modified on
2017 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029711

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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