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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004061
Receipt No. R000004867
Scientific Title A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
Date of disclosure of the study information 2010/08/18
Last modified on 2017/10/03

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Basic information
Public title A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
Acronym A phase II study of Bortezomib for ATL
Scientific Title A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Tamura
Organization Fukuoka University
Division name Division of Oncology, Hematology and Infectious Disease
Zip code
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
1st name
Middle name
Last name Kenji Ishitsuka
Organization PS341-ATL Coordinating Office
Division name Division of Oncology, Hematology and Infectious Disease, Fukuoka University
Zip code
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

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 Terminated
Date of protocol fixation
2010 Year 07 Month 21 Day
Date of IRB
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

Other
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

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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