UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000457 |
|---|---|
| Receipt number | R000000551 |
| Scientific Title | A prospective non-randomised phase II study to assess the safety and efficacy of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation for hematological malignancies (C-SHOT 0505) |
| Date of disclosure of the study information | 2006/07/31 |
| Last modified on | 2017/02/06 09:18:47 |
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Basic information
Public title
A prospective non-randomised phase II study to assess the safety and efficacy of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation for hematological malignancies (C-SHOT 0505)
Acronym
A phase II study of melphalan combined with fludarabine for UBMT (C-SHOT 0505)
Scientific Title
A prospective non-randomised phase II study to assess the safety and efficacy of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation for hematological malignancies (C-SHOT 0505)
Scientific Title:Acronym
A phase II study of melphalan combined with fludarabine for UBMT (C-SHOT 0505)
Region
| Japan |
Condition
Condition
Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome, Chronic myelomonocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to assess the safety and efficacy of melphalan combined with fludarabine as a reduced intensity-conditioning regimen for patients ineligible for conventional preparative regimen due to high age between 40 and 55 years or even under 40 years with significant co-morbidity who receive unrelated bone marrow transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival at 100 days after transplantation
Key secondary outcomes
Time to hematopoietic recovery, grade of treatment-related toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, overall survival at 1-year after transplantation, disease-free survival at 1-year after transplantation
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 25mg/square meter for 5 days and melphalan 90mg/square meter for 2 days will be used as conditioning regimen. Subsequently, bone marrow graft from unrelated donor will be transplanted under immunosuppressive treatment with short-term methotrexate and tacrolimus.
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
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Either patients with AML or ALL or CML or MDS or CMMOL (except CML in blast crisis), (2)(a)Age between 40 and 55 years and, 1.Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) is 0-2 point at one month before the transplantation, (b)Age under 40 years, 1.serum bilirubin 1.5-3.0mg/dl or AST/ALT 2XULN and 5xULN, 2.serum creatinin 1.5-2.0mg/dl, 3.left ventricular ejection fraction 30-50%, 4.past history of cardiac event, 5.PaO2 50-90mmHg without oxygen inhalation, (3) Available of HLA-A/B/DRB1 identical or DRB1-genotypical or DR-serological 1-locus mismatched unrelated bone marrow donor, (4) First high dose therapy with hematopoietic stem cell support including auto transplantation, (5)PS 0-2, (6) Written informed consent to participate the trial
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 anti-neoplastic agent within 4 weeks before transplantation (4)30% or more tumor cells of total nucleated cell count in bone marrow specimen before 28 days of registration (5)Pregnant or during breast feeding, (6)Uncontrolled another neoplastic disease, (7)Uncontrolled active psychiatric disease,(8)Uncontrolled active infection, (9)central nervous system involvement of tumor cells (10)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (11) Available of a suitable related donor, (12)Patients suggested as ineligible by their attending physician
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Morishita |
Organization
JA Aichi Konan Kosei Hospital
Division name
Department hematology and oncology
Zip code
Address
137 Omatsubara,Takaya-cho,Konan,Aichi,Japan
TEL
0587-56-4155
m59@mb.ccnw.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2145
Homepage URL
http://www.c-shot.or.jp/study/0505
tnishida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Blood and Marrow Transplantation Group
Institute
Department
Personal name
Funding Source
Organization
Nagoya Blood and Marrow Transplantation Group
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
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
| 2006 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.c-shot.or.jp/study/0505/outline/
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
No longer recruiting
Date of protocol fixation
| 2006 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000551
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