UMIN-CTR Clinical Trial

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
Email	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
Email	myoshimi@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033855