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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002214
Receipt No. R000002482
Scientific Title Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)
Date of disclosure of the study information 2009/07/17
Last modified on 2012/07/02

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Basic information
Public title Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)
Acronym Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)
Scientific Title Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)
Scientific Title:Acronym Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)
Region
Japan

Condition
Condition Acute myeloid leukemia
AML with multilineage dysplasia
Myelodysplastic syndrome
Acute lymphoblastic leukemia
Chronic myeloid leukemia
Adult T cell leukemia/lymphoma
Malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Determine the safety and efficacy of cord blood transplantation after myeloablative or non-myeloablative conditioning regimen in patients with hematological malignancies who have an indication for allogeneic stem cell transplantation but lack a HLA-identical related, a HLA single-antigen mismatched related donor or a HLA identical (by serological typing) unrelated donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Engraftment rate
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 Myeloablative conditioning regimen consists of Ara-C, cyclophosphamide and TBI12Gy.
Nonmyeloablative conditioning regimen consists of fludarabine 180mg/m2, intravenous busulfan 8mg/kg,and TBI 4Gy.
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
16 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with hematologic malignancies who have an indication for allogeneic stem cell transplantation
2. Patients lacking HLA-matched (by serological typing) related, HLA single-antigen mismatched related donor or HLA-identical (by serological typing) unrelated donor
3. ECOG PS 0-1
4. Informed consent

Eligible diseases and status
I. AML: regardless of disease status
II. AML with multilineage dysplasia (regardless of disease status)
III.MDS
i)RAEB1,2
ii)RA with transfusion dependence or RA with poor risk cytogenetics
IV. ALL (including Ph ALL): regardless of disease status
V. CML: Chronic phase resistant to tyrosine kinase inhibitors, Acceleration phase or Blast crisis
VI:ATLL acute type or lymphoma type: regardless of disease status
VII: Malignant lymphoma (regardless of disease status

Eligibility for the myeloablative conditioning regimen (patient must fulfill all the following criteria 1-3)
1. Age: 16=<, =<55 years old at enrollment
2. Normal function of major organ: (must fulfill the following criteria a-d)
a. %VC>40%, FEV1.0%>50% and SaO2>70mmHg (SpO2>94%) on room air
b. EF>50%
c. Serum creatinine level <1.5mg/dl
d. T-Bil<1.5mg/dl and ALT within normal limits
3. No history of high-dose chemotherapy (or radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source

Eligibility for the nonmyeloablative conditioning regimen (patient must fulfill any of the following criteria)
1. Age: =>56 years old at enrollment
2. Major organ dysfunction confirmed within the last 28 days before enrollment
a.30%=<%VC=<40%, 40%=<FEV1.0%=<50%, 50mmHg=<SpO2=<70mmHg (SpO2 90-94%) on room air
b. EF: =>30%, =<50%
c. Serum creatinine level: 1.5-2.0mg/dl
d. T-Bil: 1.5-2.0mg/dl or ALT: more than normal limit and within 3 times of UNL
3. A history of high-dose chemotherapy (radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source
Key exclusion criteria 1. Dysfunction of major organ which meets any of the following criteria.
a. T-Bil > 2.0mg/dl
b. Cre > 2.0mg/dl
c. EF >30%
d. %VC <30%, FEV1.0% <40% or SaO2 < 50mmHg on room air (SpO2 <90%)
e. AST: beyond 3 times of UNL
2. Active infection
3. Poorly controlled diabetes mellitus despite the use of insulin
4. Poorly controlled hypertention
5. Severe complications including heart failure, coronary failure, myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia
6. Pregnant, nursing of possible fertile woman
7. Severe mental disorder who is unlikely to be able to participate in the study
8. A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplantation
9. HIV antibody positivity
10. No indication for this study judged by physician in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Terada
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mika Nakamae
Organization Osaka City University, Graduate School of Medicine
Division name Clinical research center for hematological malignancies
Zip code
Address
TEL
Homepage URL
Email crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute Hematology, Osaka City University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Hematology, Osaka City University, Graduate School of Medicine
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
2009 Year 07 Month 17 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 Terminated
Date of protocol fixation
2009 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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
2009 Year 07 Month 16 Day
Last modified on
2012 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002482

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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