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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004338
Receipt No. R000004968
Scientific Title Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies
Date of disclosure of the study information 2010/10/06
Last modified on 2016/10/05

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Basic information
Public title Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies
Acronym Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies
Scientific Title Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies
Scientific Title:Acronym Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies
Region
Japan

Condition
Condition Hematologic malignancies with an indication for allogeneic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of UCB transplantation following low-dose TBI containing reduced intensity conditioning for hematologic malignancy patients with advanced age or organ dysfunction, who lack a suitable related or unrelated donor, or who require urgent allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Day 60 survival rate of patients with successful engraftment after transplantation
Key secondary outcomes (1) Overall survival and progression free survival at day 100
(2) Non-relapse mortality at day 100
(3) Rate of primary graft failure, secondary graft failure
(4) Time to hematopoietic recovery and achievement of complete donor T-cell chimerism
(5) Incidence and severity of acute GVHD and chronic GVHD
(6) Regimen-related toxicity
(7) Rate of relapse
(8) Incidence of bacterial, fungal and viral infection
(9) Immune reconstitution after transplantation

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 Conditioning regimen with fludarabine 25mg/m2 for 5 days, melphalan 40mg/m2 for 2 days and TBI at a dose of 2 Gy on day-1 are used.
GVHD prophylaxis consists of tacrolimus given at 0.03mg/kg/day as continuous intravenous infusion from day-1 and mycophenolate mofetil at 750mg orally given three times a day from day 0.
UCB unit with more than 2.5 x 10^7/kg of cryopreserved total nucleated cell dose, which is serologically matched for greater than 4 of 6 HLA antigens is used.
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 are incurable by conventional treatments and therefore have an indication for allo-HSCT
Eligible diseases;
(a)AML
1. First CR with high risk
2. Second CR or greater
3. Relapse or failure to achieve CR by the first induction chemotherapy
(b)MDS
1. Poor prognosis MDS with IPSS scores of int-2 or higher
2. Patinets with transfusion-dependent MDS who require RBC transfusion over 2 units per week or platelet transfusion over 10 units per week
(c)CML
1. Second CP or greater
2. First CP or tyrosine kinase inhibitor failure
(d)Malignant lymphoma
1. Indolent lymphoma (including CLL)
First relapse/progression,or greater, regardless of sensitivity to prior chemotherapy
(e)ALL (including Ph positive ALL)
1. CR
(2) Patients lacking a 5/6 or 6/6 HLA-A/B/DR serologically matched related donor
(3) Patients lacking an HLA-A/B/DR serologically matched unrelated donor, patients who require urgent transplantation due to disease status but can hardly receive transplantation from unrelated HLA-matched donor in a timely fashion
(4) ECOG performance status score: 0-2
(5) Patients who are not candidates for myeloablative transplantation
(6) Written informed consent before participation
Key exclusion criteria (1)Patients who have any major organ dysfunction as follow
(a) Heart: Ejection fraction <30% at rest
(b) Lung: %VC<30% or FEV1.0%<40% or PaO2<60mmHg(SpO2<90%) on room air
(c) Kidney: serum creatinine level >2.0 mg/dl
(d) Liver: total bilirubin level >2.0 mg/dl or ALT>3.0 x ULN (upper limit of normal) or chronic active hepatitis or cirrhosis
(2) Poorly controlled hypertention
(3) Positivity for HIV antibody
(4) Uncontrolled active infections
(5) Uncontrolled central nervous system involvement
(6) Pregnant, nursing or possibly pregnant woman
(7) Patients with mental disorder who are considered difficult to participate in the study
(8) Known hypersensitivity to any of the drugs in the conditioning regimen or drugs used for GVHD prophylaxis
(9) Patients with positive donor-specific HLA antibodies(DSA)
(10) Engraftment failure after allogeneic hematopoietic stem cell transplantation
(11) Inappropriate to participate in this study as judged by the physician in charge
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hino
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 hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Nakamae
Organization Osaka City University, Graduate School of Medicine
Division name Hematology(Clinical research center for hematological malignancies )
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Homepage URL
Email crc-hematology@med.osaka-cu.ac.jp

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

Funding Source
Organization none
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
2010 Year 10 Month 06 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
2010 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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
2010 Year 10 Month 06 Day
Last modified on
2016 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004968

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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