UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000354 |
|---|---|
| Receipt number | R000000448 |
| Scientific Title | Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies |
| Date of disclosure of the study information | 2006/03/10 |
| Last modified on | 2012/09/10 13:45:06 |
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Basic information
Public title
Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies
Acronym
Dose-reducing study of Campath-1H
Scientific Title
Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies
Scientific Title:Acronym
Dose-reducing study of Campath-1H
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find the optimal dose of Campath-1H by stepwise dose-reduction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Donor cell engraftment and the incidence of grade III to IV acute GVHD within 60 days after transplantation
Key secondary outcomes
Relapse rate and non-relapse mortality at 1 year
Overall survival at 1 year
Immune reconstitution
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
To find minimum tolerated dose by reducing the dose of Campath-1H with evaluation of the incidence of grade III to IV acute GVHD.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with hematological malignancies which can not be cured without transplantation.
2. Patients who have a 2- or 3-loci-mismatched haploidentical related donor with good physical condition.
Key exclusion criteria
1. Patients who have an available HLA-A/B/DR-matched or 1-locus-mismatched donor in family members.
2. Patients who have an HLA-matched unrelated donor and whose disease status can wait for time-consuming donor coordination.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
University of Tokyo Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
University of Tokyo Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
http://www.h.u-tokyo.ac.jp/mukin/
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 03 | Month | 10 | 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
| 2005 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 09 | Day |
Last modified on
| 2012 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000448
