Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Study of Frontline H Pylori Eradication in the Treatment of Early-stage Extragastric MALT Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02987127
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of extragastric MALToma remains unclear. In addition to anecdotal case reports showing histologic regression of extragastric MALTomas after antibiotics, our explorative study found that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21 HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the treatment of early-stage low-grade extragastric MALToma.

Condition or disease
Mucosa-Associated Lymphoid Tissue Lymphoma

Detailed Description:

Through a prospective trial of frontline HPE in the treatment of early-stage extragastric MALToma, investigators will evaluate and investigate the following issues:

  1. The CR and partial remission (PR) rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
  2. The durability of CR and PR (relapse-free survival) after antibiotics treatment (HPE) in early-stage extragastric MALToma
  3. The assessment of the evidence of bacterial infection, such as HP, in extragastric MALToma.
  4. The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of Frontline Helicobacter Pylori Eradication Therapy in the Treatment of Early-stage Extragastric Mucosa-associated Lymphoid Tissue Lymphoma
Study Start Date : February 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. The complete and partial remission rate for antibiotics as 1st-line therapy for stage IE-IIE1 extragastric MALT lymphoma. [ Time Frame: 5 years ]
    The complete remission rate and partial remission rate for antibiotics (HP eradicaiton) as 1st-line therapy for early-stage extragastric MALT lymphoma


Secondary Outcome Measures :
  1. The overall survival of early-stage extragastric MALT lymphoma patients who received frontline HP eradication therapy [ Time Frame: 5 years ]
  2. The assessment of the evidence of bacterial infection in all extragstric MALT lymphoma [ Time Frame: 5 years ]
  3. The usefulness of pattern of NF-κB, BCL10, BAFF, API2-MALT1, and IgH-MALT1 by IHC staining or FISH in prospectively predicting the antibiotics responsiveness of extragastric MALT lymphoma [ Time Frame: 5 years ]
  4. The relapse-free survival of early-stage extragastric MALT lymphoma patients who received antibiotics as 1st-line therapy [ Time Frame: 5 years ]

Other Outcome Measures:
  1. The complete remission rate and durability of second-line chemotherapy with chlorambucil plus prednisolone for progressive disease after frontline HP eradication therapy [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Extragastric mucosa-associated lymphoid tissue lymphoma
Criteria

Inclusion Criteria:

  1. The patients must have histologically confirmed low-grade mucosa-associated
  2. lymphoid tissue lymphoma of extragastric sites.
  3. Patients must have evaluable disease by physical examination, endoscopy (also include colonfibroscopy, and bronchoscopy) or computed tomography.
  4. Patients must receive examination of documented HP infection or not before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.
  5. Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
  6. Patients must have signed the informed consent and agree to provide achieved pathologic material for immunohistochemical staining of BCL10, NF-KB, BAFF, CagA, CagA-signaling molecules, for fluorescence in situ hybridization study for t(11;18)(q21;q21)/API2-MALT1 and t(14;18)(q32;q21)/IGH-MALT1 determination, and for PCR of Chlamydia psittaci and Borrelia burgdorferi.
  7. Patients must have signed the informed consent and agree to provide achieve blood samples for CYP2C19 genetic polymorphisms evaluation and potential serum molecular studies, such as serum BAFF level

Exclusion Criteria:

  1. In the diagnosis of the disease over the past five years with a history of other cancers but non-melanoma skin cancer, breast and cervical carcinoma in situ carcinoma in situ (leafy or tubular) can still meet the conditions of admission to this case study
  2. Patients receiving chemotherapy or radiotherapy of nodules outside the low-grade malignant lymphoma, but has not yet been cured, the excluded
  3. The second more, and not in the lymph nodes adjacent to the tumor (IIE-2 period or more), the excluded
  4. The state can not afford this clinical cardiopulmonary ㄧ inspection after the test series, the excluded
  5. suffering from primary gastric outside MALToma before and had received chemotherapy or radiation therapy in patients of.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987127


Contacts
Layout table for location contacts
Contact: Sung-Hsin Kuo, M.D.,Ph.D +886-2-23123456 ext 67144 shkuo101@ntu.edu.tw
Contact: Shu-Ling Wu, MS +886-2-23123456 ext 67573 shulingwu.ntuh@gmail.com

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Sung-Hsin Kuo, M.D.,Ph.D    +886-2-23123456 ext 67144    shkuo101@ntu.edu.tw   
Contact: Shu-Ling Wu, MS    +886-2-23123456 ext 67573    shulingwu.ntuh@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sung-Hsin Kuo, M.D.,Ph.D National Taiwan University Hospital

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02987127     History of Changes
Other Study ID Numbers: 201511025MINC
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin