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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000600
Receipt No. R000000710
Scientific Title A prospective non-randomized phase II study to assess the efficacy of unrelated cord blood transplantation for adult unfavorable hematological malignancies (C-SHOT 0601)
Date of disclosure of the study information 2007/02/07
Last modified on 2016/08/15

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Basic information
Public title A prospective non-randomized phase II study to assess the efficacy of unrelated cord blood transplantation for adult unfavorable hematological malignancies (C-SHOT 0601)
Acronym A phase II study to assess the efficacy of unrelated cord blood transplantation for adult hematological malignancies (C-SHOT 0601)
Scientific Title A prospective non-randomized phase II study to assess the efficacy of unrelated cord blood transplantation for adult unfavorable hematological malignancies (C-SHOT 0601)
Scientific Title:Acronym A phase II study to assess the efficacy of unrelated cord blood transplantation for adult hematological malignancies (C-SHOT 0601)
Region
Japan

Condition
Condition Patients with acute myeloid leukemia/acute lymphocytic leukemia/myelodysplastic syndrome/chronic myelomonocytic leukemia categorized as high risk group
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 For patients with relapsed disease or high-risk of relapse, allogeneic hematopoietic transplantation would be indicated. In this study, patients without suitable related or unrelated donor will be transplanted with unrelated cord blood after conditioning including cyclophosphamide, cytosine arabinoside with/without G-CSF and total body irradiation. The purpose of this study is to assess the safety and efficacy of the UCBT.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes survival rate of patients with successful engraftment at 180 days post-transplant
Key secondary outcomes Time to hematopoietic recovery, grade of treatment-associated toxicity by day28, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, treatment-related mortality rate at day180, relapse rate at day180, disease-free survival 2years after transplantation, overall survival 2years 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 G-CSF combined cytosine arabinoside 2g/square meter x4 +cyclophosphamide 60mg/kg x2 +TBI12Gy will be used as conditioning regimen for AML/MDS/CMMoL patients. For ALL patients, cyclophosphamide 60mg/kg x2 +TBI12Gy will be used as conditioning regimen. Subsequently, unrelated cord blood unit 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 (A) AML 1.Pts in CR1 (a)pts with unfavorable or unknown karyotype (b)FAB-M0/M6/M7 (c)pts with intermediate karyotype and non-CR after first-line induction (d)FAB-M3/M3v failed salvage treatment using As2O3, or ATRA, or other synthetic retinoids. 2.CR2 (except pts with t(15;17) in molecular CR) (B)B-ALL 1.High-risk ALL pts in CR1 where high-risk is defined as; (a)pts with evidence of t(9;22) (b)elevated WBC at presentation: >30000/mm3 and >30 years old (c)pts with evidence of 11q23 or MLL gene rearrangement (d)failed to achieve CR after 4 weeks of induction 2. CR2 or later CR (C)T-ALL 1.High-risk T-ALL pts in CR1 where high-risk is defined as; (a)>30 years old (b)elevated WBC at presentation >50000/mm3 2.CR2 (D)MDS Pts categorized as intermediate-2 or high-risk by IPSS score system (E)CMMoL Pts categorized as intermediate-2 or high-risk by CMML scoring system. Pts with MDS and CMMoL in CR1 or chemo-naive are eligible. Pts with MDS and CMMoL treated only with Azacitidine are also eligible.
(1)Age between 16 and 55 years
(2)(a)Performance states (ECOG)=0 or 1
(b)Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI)=0 at registration
Pts with transient liver dysfunction are eligible.
(3)UCB units are available as follows; (a)HLA-A/B/DR serologically match more than 4/6 (b)TNCC of UCB unit is 2.0 x 10E7/kg recipient weight as of frozen
(4)First high dose therapy with hematopoietic cell support including auto transplantation
(5)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 gemtuzumab ozogamicin within 6 month before transplantation (4)Pregnant or during breast feeding (5)Uncontrolled another neoplastic disease (6)Uncontrolled active psychiatric disease (7)Uncontrolled active infection (8)Allergic history to drugs used in the conditioning regimen or GVHD prophylaxis regimen (9)Patients suggested as ineligible by their attending physician
Target sample size 60

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
Email miyamu@nagoya-1st.jrc.or.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,Nogoya,Aichi,Japan
TEL 052-744-2145
Homepage URL http://www.c-shot.or.jp/study/0601/outline/
Email tnishida@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2007 Year 02 Month 07 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 No longer recruiting
Date of protocol fixation
2006 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 02 Month 07 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000710

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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