UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000357 |
|---|---|
| Receipt number | 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 13:05:55 |
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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
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
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
GCP-ISS HE0402 group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000454
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