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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000325
Receipt No. 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

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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
Email

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
Email tseit@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Blood and Marrow Transplantation Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000419

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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