UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025831 |
|---|---|
| Receipt number | R000029525 |
| Scientific Title | High-dose clarithromycin monotherapy for Helicobacter pylori-negative or -eradicated gastrointestinal MALT lymphomas |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2019/03/20 08:24:52 |
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Basic information
Public title
High-dose clarithromycin monotherapy for Helicobacter pylori-negative or -eradicated gastrointestinal MALT lymphomas
Acronym
High-dose CAM monotherapy for MALT lymphomas
Scientific Title
High-dose clarithromycin monotherapy for Helicobacter pylori-negative or -eradicated gastrointestinal MALT lymphomas
Scientific Title:Acronym
High-dose CAM monotherapy for MALT lymphomas
Region
| Japan |
Condition
Condition
Gastrointestinal MALT lymphomas
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability and efficacy of high-dose clarithromycin (CAM) monotherapy in patients with Helicobacter pylori-negative or eradicated gastrointestinal MALT lymphomas.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate (ORR), defined as complete remission (CR) and partial remission (PR).
Key secondary outcomes
1) CR rate after 12, 26 and 52 weeks after the start of this therapy.
2) Progression-free survival after 3 years.
3) Adverse events.
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
Patients were treated with 4 courses of oral administration of clarithromycin (CAM) 2g/day, once daily, days 1-14, every 21 days.
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) Patients with gastrointestinal MALT lymphoma who is negative for H. pylori infection, or who had not achieved CR at least 6 months after H. pylori eradication.
2) Patients with 20 years or older.
3) Written informed consent was obtained.
Key exclusion criteria
1) Past history of allergy for CAM.
2) Taking drugs contraindicated for concomitant use with CAM, including calcium-channel blockers.
3) Prolonged QTc, sinus bradycardia (HR <50 bpm), or severe atrioventricular block detected by ECG.
4) Past history of gastrectomy.
5) Combined malignancies other than MALT lymphoma.
6) Severe renal dysfunction (eGFR<30 mL/min/1.73m2).
7) Liver dysfunction
8) Pregnant or possible pregnant women.
9) Others
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Nakamura |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
020-8505
Address
Uchimaru 19-1, Morioka 020-8505, Japan
TEL
019-651-5111(+2311)
shonaka@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Nakamura |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
020-8505
Address
Uchimaru 19-1, Morioka 020-8505, Japan
TEL
019-651-5111(+2311)
Homepage URL
shonaka@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine,
Division of Gastroenterology,
Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
JAPANGAST Study Group (JGSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hakodate National Hospita; Okayama University; Hiroshima University; Kyushu University; Hokkaido University; Ibaraki Prefectural Central Hospital; Fukuoka Sanno Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The echics committee at Iwate Medical University Hospital
Address
Uchimaru 19-1, Morioka 020-8505, Japan
Tel
019-651-5111(+3111)
hiroaki.kawamori@j.iwate-med.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
岩手医科大学病院（岩手県）、国立病院機構函館病院（北海道）、岡山大学病院（岡山県）、広島大学病院（広島県）、九州大学病院（福岡県）、北海道大学病院（北海道）、茨城県立中央病院・茨城県地域がんセンター（茨城県）、福岡山王病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
13
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029525
