UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000600 |
|---|---|
| Receipt number | 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 | 2021/02/17 18:20:53 |
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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 | Koichi |
| Middle name | |
| Last name | Miyamura |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of Hematology
Zip code
453-8511
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya, Aichi, Japan
TEL
052-481-5111
miyamu@nagoya-1st.jrc.or.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku,Nogoya,Aichi,Japan
TEL
052-744-2145
Homepage URL
http://www.c-shot.or.jp/study/0601/outline/
tnishida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Blood and Marrow Transplantation Group
Institute
Department
Personal name
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
Nagoya University Certified Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2947
ethics@med.nagoya-u.ac.jp
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
Completed
Date of protocol fixation
| 2006 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2007 | Year | 01 | Month | 29 | Day |
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
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000710
