UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029635 |
|---|---|
| Receipt number | R000033855 |
| Scientific Title | Safety and efficacy of lenalidomide for patients with relapsed or refractory adult T cell leukemia/lymphoma post allogeneic hematopoietic stem cell transplantation, multi-institutional prospective observational trial |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2022/10/24 10:06:40 |
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Basic information
Public title
Safety and efficacy of lenalidomide for patients with relapsed or refractory adult
T cell leukemia/lymphoma post allogeneic hematopoietic stem cell transplantation, multi-institutional prospective observational trial
Acronym
Safety and efficacy of lenalidomide for relapsed or refractory ATL post allo-SCT
Scientific Title
Safety and efficacy of lenalidomide for patients with relapsed or refractory adult
T cell leukemia/lymphoma post allogeneic hematopoietic stem cell transplantation, multi-institutional prospective observational trial
Scientific Title:Acronym
Safety and efficacy of lenalidomide for relapsed or refractory ATL post allo-SCT
Region
| Japan |
Condition
Condition
Adult T-cell leukemia-lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of lenalidomide for patients with relapsed or refractory
adult T-cell leukemia-lymphoma post allogeneic hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year overall survival after hematopoietic stem cell transplantation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. relapsed or refractory adult T-cell leukemia-lymphoma patients who will be treated with lenalidomide
2. Positive for HTLV-1 antibody
3. Written informed consent
4. Compliance to Revmate
Key exclusion criteria
1. History of lenalidomide administration after allogeneic hematopoietic stem cell transplantation
2. Plant to move within one year after registry
3. Inappropriate condition by physician's decision
4. Pregnancy or under breast-feeding or plat to pregnant during registry
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishitsuka |
Organization
Kagoshima University Hospital
Division name
Department of Hematology and Immunology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5934
kenji-i@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yoshimitsu |
Organization
Kagoshima University Hospital
Division name
Department of Hematology and Immunology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5934
Homepage URL
myoshimi@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Clinical hematology oncology treatment study group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
Tel
099-275-5934
crmc@m2.kufm.kagoshima-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
公益財団法人慈愛会 今村総合病院(鹿児島県）、国立病院機構 九州がんセンター（福岡県）、大分県立病院（大分県）、日本赤十字社長崎原爆病院（長崎県）、佐世保市立総合病院（長崎県）、国立病院機構 熊本医療センター（熊本県）、熊本大学医学部附属病院（熊本県）、大分大学医学部附属病院（大分県）、長崎大学（長崎県）、名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Immune monitoring as an accompanying research
Management information
Registered date
| 2017 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033855
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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