UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003811 |
|---|---|
| Receipt number | R000004365 |
| Scientific Title | Reduced-intensity cord blood transplantation (RI-CBT) for refractory hematological malignancies |
| Date of disclosure of the study information | 2010/06/23 |
| Last modified on | 2016/01/27 18:53:51 |
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Basic information
Public title
Reduced-intensity cord blood transplantation (RI-CBT) for refractory hematological malignancies
Acronym
Reduced-intensity cord blood transplantation (RI-CBT)
Scientific Title
Reduced-intensity cord blood transplantation (RI-CBT) for refractory hematological malignancies
Scientific Title:Acronym
Reduced-intensity cord blood transplantation (RI-CBT)
Region
| Japan |
Condition
Condition
Refractory hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of a combination of fludarabine, cyclophosphamide and total body irradiation as a conditioning regimen of reduced-intensity cord blood transplantation and prophylaxis of GVHD with tacrolimus and short term methotrexate for refractory hematological malignancies who have an indication for allogeneic stem cell transplantation but lack an ideal donor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Survival rate of patients with successful engraftment at 60 days post-transplant
Key secondary outcomes
(1)Time to hematopoietic recovery,
(2)grade of treatment-associated toxicity by day28, (3)incidence and severity of acute GVHD, (4)incidence and severity of pre-engraftment syndrome , (5)incidence of engraftment syndrome,
(6)incidence and severity of chronic GVHD, (7)treatment-related mortality rate at day100, (8)relapse rate at day100, (9)disease-free survival 1years after transplantation, (10)overall survival 1years after transplantation, (11)cause of death, (12)achievement of complete chimera at day 60
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
The purpose of this study is to investigate the efficacy of a combination of fludarabine, cyclophosphamide and total body irradiation as a conditioning regimen of reduced-intensity cord blood transplantation and prophylaxis of GVHD with tacrolimus and short term methotrexate for refractory hematological malignancies who have an indication for allogeneic stem cell transplantation but lack an ideal donor.
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)not Available of appropriate sibling donor (2)likely to fail the coordination or not get time to coordinate judged by the attending physician (3) hematological malignancies who have an indication for allogeneic stem cell transplantation
Either patients with AML or CML or MDS or CMMOL,
(a) Age between 15 and 65 years and, 1)KS is 70 or less, or 2)a) Age between 40 and 54 years ,Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is over 2 point at one month before the transplantation, b) Age under 40 years ,. Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is over 3 point at one month before the transplantation. (b)
(b) First allogenic stem cell transplantation
(c) Written informed consent to participate the trial
(d) FEV1%/ predicted vital capacity is 30% or more of predictive value
(e) AST/ALT is under 5xULN
(f) serum creatinin is under 3xULN
(g) left ventricular ejection fraction is over 40%
Key exclusion criteria
(1)Positive for HIV antibody and/or HBs antigen and/or HCV antibody.(2)Graft manipulation such as T-cell depletion .(3)History of administration of gemtuzumab ozogamicin within 6 month before transplantation.(4)Pregnant or during breast feeding. (5)Uncontrolled active psychiatric disease.
(6)Uncontrolled active infection.
(7)Allergic history to drugs used in the conditioning regimen or GVHD prophylaxis regimen. (8)Patients with severe organ dysfunction. (9)Patients suggested as ineligible by their attending physician.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Miyamura |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of Hematology
Zip code
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya, Aichi, Japan
TEL
052-481-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Sawa |
Organization
Anjo Kosei Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
28 Higashihirokute, anjyo-cho,anjyo
TEL
0566-75-2111
Homepage URL
sawa@kosei.anjo.aichi.jp
Sponsor or person
Institute
Nagoya Blood and Marrow Transplantation Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 23 | 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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004365
