UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000325 |
|---|---|
| Receipt number | R000000419 |
| Scientific Title | A dose finding study of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation |
| Date of disclosure of the study information | 2006/02/07 |
| Last modified on | 2011/10/21 11:56:40 |
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Basic information
Public title
A dose finding study of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation
Acronym
A dose finding study of melphalan combined with fludarabine for UBMT (C-SHOT 0502)
Scientific Title
A dose finding study of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation
Scientific Title:Acronym
A dose finding study of melphalan combined with fludarabine for UBMT (C-SHOT 0502)
Region
| Japan |
Condition
Condition
Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome,Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to determine the recommended dose of melphalan combined with fludarabine as a reduced intensity-conditioning regimen inducing a rapid and proper engraftment for patients with an age between 40 and 65 years who receive unrelated bone marrow transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Achievement of full donor chimerism of T-cells at 28 days post-transplant
Key secondary outcomes
(1) Disease-free survival after transplantation, (2) Overall survival after transplantation, (3) Chimerism of each cell fraction after transplantation, (4) Incidence and severity of acute GVHD, (5) Incidence and severity of chronic GVHD, (6) Grade of treatment-related toxicity, (7) Time to hematopoietic recovery
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
Dose determination of melphalan to attain the full-donor chimerism of 28 days post-transplant by using the modified continual reassessment method
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Either patients with AML or ALL or CML or MDS or NHL or HL (except primary induction failure of acute leukemia), (2) More than 2 courses of intensive chemotherapy prior to transplantation, (3) 1.Age between 40 and 65 years and, (a)Karnofsky score equal to or less than 70 or (b)Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI)equal to or more than one point at one month before the transplantation, 2.Age between 55 and 65 years, (4) Available of HLA-identical or DRB1-mismatched unrelated bone marrow donor, (5) First high dose therapy with hematopoietic cell support including auto transplantation, (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) Pregnant or during breast feeding, (4) Uncontrolled psychiatric disease, (5) Uncontrolled active infection, (6) Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (7) Available of a suitable related donor, (8) Impaired organ function, (a) left ventricular ejection fraction smaller than 40%,(b) DLCO/FEV1.0/TLC equal to or less than 30%, (c) Total bil equal to or more than 2xULN (NCI-CTCAE Grade 3), (d) AST/ALT equal to or more than 5xULN (NCI-CTCAE Grade 3), (e) serum creatinine equal to or more than 3xULN (NCI-CTCAE Grade 3), (f) Karnofsky score equal to or less than 50
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Morishita |
Organization
JA Aichi Showa Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
46 Nobaku, Nobaku-cho, Konan, Aichi, Japan
TEL
0587-56-4155
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seitaro Terakura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2145
Homepage URL
http://www.c-shot.or.jp/study/0502
tseit@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 | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2005 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 06 | Day |
Last modified on
| 2011 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000419
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