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)

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 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)

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

Value
https://center6.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