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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000354
Receipt No. 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

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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
Email

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/
Email ycanda-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000448

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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