UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004061 |
|---|---|
| Receipt number | 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 21:52:44 |
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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
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
kenjiishitsuka@fukuoka-u.ac.jp
Sponsor or person
Institute
PS341-ATL Coordinating Office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004867
