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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000357
Receipt No. R000000454
Scientific Title Evaluation of the safety and efficacy of allogenic hematopoietic stem cell transplantation (HSCT) from HLA-mismatched related donors using alemtuzumab in patients with hematological malignancies.
Date of disclosure of the study information 2006/03/20
Last modified on 2012/09/12

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Basic information
Public title Evaluation of the safety and
efficacy of allogenic hematopoietic stem cell transplantation (HSCT) from HLA-mismatched related donors using alemtuzumab in patients with hematological malignancies.
Acronym HLA-mismatched HSCT using alemtuzumab
Scientific Title Evaluation of the safety and
efficacy of allogenic hematopoietic stem cell transplantation (HSCT) from HLA-mismatched related donors using alemtuzumab in patients with hematological malignancies.
Scientific Title:Acronym HLA-mismatched HSCT using alemtuzumab
Region
Japan

Condition
Condition Hematological malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the appropriate dose of alemtuzumab for allogeneic HSCT from 2- or 3-loci-mismatched related donors and to investigate whether such HSCT can be safely performed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Survival on day 60 after transplantation
Engraftment within 60 days
Incidence of grade III to IV acute GVHD within 60 days

Key secondary outcomes • Progression-free survival at day 365
• Progression-free mortality at day 365
• Regimen-related toxicity
• Incidence of infectious disease
• Overall survival at day 365
• Anti-tumor effects

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 Alemtuzumab is added to the TBI-based or fludarabine-based regimens at 0.16 – 0.25 mg/kg per day for 6 days (days -8 to -3).
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1)Disease
(a) Acute myelogenous leukemia(AML)
 Refractory case (other than CR1)
 AML secondry to MDS (including CR1)
(b) Acute lymphocytic leukemia (ALL)
 Refractory case (other than CR1)
 Patients who did not achieve CR within 50 days after the initiation of the therapy.
 Philadelphia-positive ALL
(including CR1)
(a) Chronic myelogenous leukemia (CML)
 Advanced case (other than CP1)
(b) Myelodysplastic syndrome (MDS)
 Neutrophil count below 500/mm3 (for 1 month or longer)
 More than 20% blastic cells in bone marrow
(c) Malignant lymphoma (ML)
 Refractory case
 Relapse after autologous transplantation
(2) Patients who do not have an available HLA-A/B/DR-matched or 1-locus-mismatched donor in family members.
(3) Patients who do not have an HLA-matched unrelated donor or whose disease status precluded time-consuming donor coordination.
(4)ECOG performance status of 0 or 1 .
(5)Good major organ functions.
(6)CD34-positive cells harvested from the donor at least 3.0 x 106 per kg of patient body weight.
Key exclusion criteria (1) Adult T cell leukemia/lymphoma
(2) Diabetes uncontrollable even with regular insulin use.
(3) Uncontrollable hypertension.
(4) Active infection.
(5) Refractory hematological malignancies with bone marrow involvement more than 30% of tumor cells.
(6) Active central nervous system involvement.
(7) Current active double cancer.
(8) Women who are or may be pregnant, or who are nursing.
(9) Uncontrollable mental illness.
(10) Hepatitis B virus antigen-positive (HBsAg or HBeAg).
(11) HIV-positive.
(12) A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, busulfan, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate).
(13) A history of hematopoietic stem cell transplantation. However, a single prior autologous transplantation is permitted.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization The University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kanda
Organization The University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email ycanda-tky@umin.ac.jp

Sponsor
Institute GCP-ISS HE0402 group
Institute
Department

Funding Source
Organization 2004 Health and Labor Sciences Research Grant (Research on Human Genome, Tissue Engineering and Food Biotechnology) of the Ministry of Health, Labor and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 20 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
2004 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2004 Year 12 Month 01 Day
Last follow-up date
2008 Year 04 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 13 Day
Last modified on
2012 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000454

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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