UMIN-CTR Clinical Trial

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
Last 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
1st 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