UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000457
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tnishida@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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.