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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030095
Receipt No. 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

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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
Email 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
Email shigemap@mac.com

Sponsor
Institute North Japan Hematology Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034360

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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