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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025831
Receipt No. 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

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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)
Email 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
Email shonaka@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University School of Medicine,
Division of Gastroenterology,
Department of Internal Medicine
Institute
Department

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)
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029525

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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