UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
Title of the study (Brief title)	A phase II study of Bortezomib for ATL
Region	Japan

Condition
Condition	Adult T-cell Leukemia/Lymphoma (ATL)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of Bortezomib for relapsed/refractory ATL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall best response
Key secondary outcomes	Safety, best response in each lesion, progression free survival, serum LDH, serum soluble IL-2 receptor, and HTLV-1 provirus DNA in PBMNCs

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	Treatment by Bortezomib
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 ATL patients after one or more prior lines of chemotherapy under the diagnosis of ATL (acute type, lymphoma type, or chronic type with unfavorable factor). 2) Aged 20 years old or older 3) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale 4) More than 4 weeks of interval from last chemotherapy for ATL to scheduled first day of protocol treatment. 5) Having a measurable lesion, or evaluable lesions either of peripheral blood or skin. 6) Adequate hematological and major organ function 7) Written informed consent
Key exclusion criteria	1) History of treatment by bortezomib 2) Hypersensitivity to bortezomib, mannitol or boron. 3) History of administration of other investigational agents within 4 weeks before informed consent. 4) Interstitial pneumonia or pulmonary fibrosis. 5) Class III or IV (NYHA) cardiac disease, and/or either of cardiac infarction within 6 months before the informed consent, uncontrollable angina, severe ventricular arrhythmia, acute coronary ischemia, or symptomatic conduction block 6) Active infection 7) Suspicious findings of central nervous invasion 8) Grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 9) Either of cardiac failure, renal failure, hepatic failure, uncontrollable hypertension or uncontrollable diabetes mellitus. 10) Psychological disturbance 11) Synchronous or metachronous malignancy 12) HBs-Ag positive or HBc-Ab positive with HBV-DNA positive 13) HCV-Ab positive, HIV positive 14) Pregnant or nursing women
Target sample size	25

Research contact person
Name of lead principal investigator	Kazuo Tamura
Organization	Fukuoka University
Division name	Division of Oncology, Hematology and Infectious Disease
Address	7-45-1 Nanakuma Jonan Fukuoka, 814-0180, Japan
TEL	092-801-1011
Email	ktamura@fukuoka-u.ac.jp

Public contact
Name of contact person	Kenji Ishitsuka
Organization	PS341-ATL Coordinating Office
Division name	Division of Oncology, Hematology and Infectious Disease, Fukuoka University
Address	7-45-1 Nanakuma Jonan Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	kenjiishitsuka@fukuoka-u.ac.jp

Sponsor
Institute	PS341-ATL Coordinating Office
Institute
Department

Funding Source
Organization	Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Clinical Hematology Oncology Treatment Study Group

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW	2010/7/30

Institutions
Institutions	福岡大学病院（福岡県） 慈愛会今村病院分院（鹿児島県） 国立病院機構熊本医療センター（熊本県） 名古屋市立大学病院（愛知県） 鹿児島大学病院（鹿児島市）

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 21 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2015 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	Published
URL releasing results
Results	Adult T-cell leukemia/lymphoma (ATL) is a malignancy of peripheral T-lymphocytes with a poor prognosis. This multicenter, two-stage, single-arm, phase II study assessed the efficacy and safety of bortezomib in patients with relapsed/refractory ATL who received at least one regimen of chemotherapy. The primary endpoint was the best overall response rate (ORR), and secondary endpoints included safety, the best response by lesions, and progression-free survival (PFS). Fifteen patients were enrolled in the first stage of this study. One partial remission (PR) and five stable disease (SD) were observed as the best overall responses, and ORR was 6.7% (95% confidence interval (C.I.) 0.17-31.95%). Responses according to disease sites were one complete remission (CR) in peripheral blood, two PR in measurable targeted lesions, and two PR in skin lesions. Progression-free survival (PFS) was 38 (95% CI; 18-106) days. All patients developed >=1 adverse events (AEs), and 80% of patients had >=1 grade 3/4 AEs; however, no new safety findings were obtained. Although these results fulfilled the planned settings to proceed to the second stage, the coordinating committee decided to terminate this study because single agent activity did not appear to be very promising for this cohort of patients.
Other related information

Management information
Registered date	2010 Year 08 Month 18 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004867