UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consolidation treatment of Lenalidomide for patients with adult T-cell leukemia/lymphoma ineligible for hematopoietic stem cell transplant.
Title of the study (Brief title)	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	Akio Shigematsu
Organization	Sapporo Hokuyu Hospital
Division name	Department of Hematology
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	Akio Shigematsu
Organization	Sapporo Hokuyu Hospital
Division name	Department of Hematology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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