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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011293
Receipt No. R000013231
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Date of disclosure of the study information 2013/07/26
Last modified on 2018/12/05

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Basic information
Public title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Acronym HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Scientific Title HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Scientific Title:Acronym HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Region
Japan

Condition
Condition Acute myeloid leukemia(AML)
Acute lymphoblastic leukemia (ALL)
Chronic myeloid leukemia (CML)
Myelodysplastic syndrome (MDS)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the safety and efficacy of HLA-haploidentical allogeneic stem cell transplantation from related donor for patients with poor-prognosis or refractory leukemia or myelodysplastic syndrome (MDS) who lack an HLA serological identical related donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Proportion of patients who survive with graft engraftment at 100 days following 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 Uncontrolled
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), Melphalan (100mg/ square meter per day for 1 day) is used as a conditioning regimen. Cyclophosphamide (25 mg/kg) is given on day 3, 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 3,000mg/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 1) Patients with poor-prognosis or
refractory leukemia or MDS who lack an
HLA serological identical related donor.
2) Patients who have an HLA
-haploidentical donor of family member
or relative
3) Age >=15 and < 70 years old
4) ECOG PS 0 or 1
5) Normal function of major organs
6) Informed consent has been acquired.

7) Patients who are in need of a prompt
allogeneic transplant
a) De novo AML: refractory to first
induction therapy or relapse after
chemotherapy
b) ALL: refractory to first induction
therapy or relapse after chemotherapy
c) CML in AP or BC: refractory to TKIs
including imatinib, dasatinib and
nilotinib
d) Patients with AML, ALL, CML or MDS
who have relapsed after allogeneic
transplant

8) Patients who have an indication for
allogeneic transplantation due to an
unfavorable prognosis but lack a
suitable related donor
a) Patients with de novo AML in the CR
with an unfavorable chromosome
abnormality including del(5q)/-5,-
7/del(7q), abn 3q, 9q, 11q, 20q, 21q,
17q, t(6;9), t(9;22) or a complex
karyotype
b) Patients with de novo AML in the CR
with normal karyotype and FLT3-ITD
mutation
c) Patients with AML with
intermediate/poor group by JALSG score
d) Patients with ALL in 1CR who have 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
e) AML, ALL in the CR state except for
1CR
f) CML in the CR state except for 1CR
g) MDS with RAEB-1, 2, AML with MRC
h) Patients with AML, ALL, or CML in CP
who have relapsed after allogeneic
transplant


Key exclusion criteria 1) Major organ dysfunction
a) Total bilirubin:>= 2.0mg/dl
b) Serum creatinine: >= 2.0mg/dl
c) 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 or possible
fertile women who may become pregnant
8) Patients with a severe mental
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) 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 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Nakamae
Organization Graduate School of Medicine, Osaka City University
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 Graduate School of Medicine, Osaka City University
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
2013 Year 07 Month 26 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
2013 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2013 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
2013 Year 07 Month 26 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013231

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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