UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030095 |
|---|---|
| Receipt number | R000034360 |
| Scientific Title | Consolidation treatment of Lenalidomide for patients with adult T-cell leukemia/lymphoma ineligible for hematopoietic stem cell transplant. |
| Date of disclosure of the study information | 2017/11/27 |
| Last modified on | 2017/11/23 20:27:10 |
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Basic information
Public title
Consolidation treatment of Lenalidomide for patients with adult T-cell leukemia/lymphoma ineligible for hematopoietic stem cell transplant.
Acronym
Consolidation Lenalidomide for Transplant Ineligible ATL Patients
Scientific Title
Consolidation treatment of Lenalidomide for patients with adult T-cell leukemia/lymphoma ineligible for hematopoietic stem cell transplant.
Scientific Title:Acronym
Consolidation Lenalidomide for Transplant Ineligible ATL Patients
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
The purpose of this study is to investigate the safety and efficacy of consolidation therapy using Lenalidomide for patients with ATL who are inedible for allogeneic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety of consolidation therapy using Lenalidomide
Key secondary outcomes
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
Daily administration of 25mg of Lenalidomide after induction therapy until disease progression or intolerance
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of either aggressive type of ATL
2. Age more than 19 years old
3. Achievement of stable disease, partial remission or complete remission
4. Inegible for stem cell transplantation
5. ECOG performance status 0-2
6. Intact organ function
7. Written informed consent of participation
Key exclusion criteria
1. Positivity for HBs antigen
2. Positivity for HIV antibody
3. Double cancers
4. Administration of lenalidomide so far
5. Using Dialysis
6. Heat failure or ischemic heart disease
7. Acute hepatitis or Liver cirrhosis
8. Active infection
9. Active thrombotic diseases
10. Allergy for thalidomide
11. Pregnant or breast-feeding woman
12. Difficult of adherence for drug administration
13. Severe mental disorder
14.An inappropriate patient judged by the medical attendant
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Shigematsu |
Organization
Sapporo Hokuyu Hospital
Division name
Department of Hematology
Zip code
Address
Higashisapporo 6-6-5-1, Shiroishi-ku, Sapporo city, Japan
TEL
+81-11-865-0111
shigemap@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Shigematsu |
Organization
Sapporo Hokuyu Hospital
Division name
Department of Hematology
Zip code
Address
Higashisapporo 6-6-5-1, Shiroishi-ku, Sapporo city, Japan
TEL
+81-11-865-0111
Homepage URL
shigemap@mac.com
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
North Japan Hematology Study Group
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 11 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034360
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
