Indolent Non-Hodgkin's LymphomaNCT00582270
Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma
An observational study of Indolent Non-Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if an infectious disease may be associated with the new lymphoma diagnosis. Infections to be tested include: 1. Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that has been associated with a particular kind of lymphoma, gastric MALT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non-Hodgkin's Lymphoma
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Follicular and non-follicular non-Hodgkin's lymphoma
Who may be able to join
- Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification2) as reviewed by a hematopathologist at Memorial Hospital.
- Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present: 1) a nodal or extranodal mass with a diameter of >7 cm, 2) involvement of at least three nodal sites [each with a diameter of >3 cm], 3) systemic symptoms, 4) plenomegaly, or 5) ureteral compression.
- No prior treatment for lymphoma is permitted.
- Karnofsky performance status > 70%
- The patient may not have a previous history of radiation therapy.
- Patient or guardian must be able to sign voluntary written consent.
- Male or female patients 18 years of age or greater.
Who cannot join
- Histologic diagnosis of intermediate grade or high grade non-Hodgkin's lymphoma.
- Histologic evidence of low grade transformation.
- Prior treatment for non-Hodgkin's lymphoma.
- Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
- GELF criteria35 for institution of systemic chemotherapy, which includes: 1) a nodal or extranodal mass with a diameter of >7 cm, 2) involvement of at least three nodal sites [each with a diameter of >3 cm], 3) systemic symptoms, 4) splenomegaly, or 5) ureteral compression.
- Prior history of malignancy within the past five years or a concurrent malignancy, with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix.
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- Karnofsky Performance Status <70%.
- Patients with a known history of HIV seropositivity.
- Patients who require therapy with systemic corticosteroids.
- Patient or responsible guardian is unable to provide written informed consent.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to determine if an infectious disease may be associated with the new lymphoma diagnosis.
Infections to be tested include:
- Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that has been associated with a particular kind of lymphoma, gastric MALT. We are interested to learn if the H. pylori infection may be associated with other indolent lymphomas.
- Hepatitis C: This virus infection of the liver has been found in association with non-follicular lymphomas in Italy. We want to determine if the infection is associated with lymphomas in the United States.
- Bacterial overgrowth of the small bowel: Since indolent lymphomas often affect the lymph nodes surrounding the small bowel, it may be possible that an infection within the bowel is stimulating lymphoma growth. This has never been demonstrated to date, and will be studied in this clinical study.
- Epstein-Barr virus: This is the virus that causes infectious mononucleosis or "mono." It has been associated with other rapidly growing lymphomas, but not indolent lymphoma.
Read the detailed description
This is a prospective observational clinical study of possible infectious disease-associated antigen drive in previously untreated patients with indolent lymphoma (follicular and nonfollicular cohorts).
Eligible patients with a new diagnosis of indolent lymphoma will be enrolled after informed consent. All patients will be tested for possible known infectious diseases that may contribute to antigen drive (H. Pylori; Hepatitis C), as well as for other infectious diseases not yet established as contributing to antigen drive (Borrelia; Chlamydia; and small bowel overgrowth). All patients will have a complete history recorded regarding other possible chronic infections, and an infectious disease consultation, as indicated.
Patients with positive antigen-drive infectious disease studies will be treated as indicated with standard antibiotic regimens and response (both infectious disease as well as lymphoma status)will be documented and recorded.
The primary objective of this study is (1) to evaluate the possible association of infectious diseases in previously untreated patients with indolent lymphoma. The secondary objective of this study is to evaluate possible lymphoma response the in patients treated for positive infectious disease studies; and to evaluate EBV immune responses in these previously untreated patients.
- Conditions
- Indolent Non-Hodgkin's Lymphoma
- Keywords
- non-hodkin's lymphoma, follicular, non-follicular, infectious disease
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Follicular Lymphoma | |
| 2 | Non-follicular Lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease status
Measured: 5 years 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 2003
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol Portlock, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582270
- Sponsor's protocol ID
- 03-012
- Status last verified
- Sep 2023
- First submitted
- 21 Dec 2007
- Last updated
- 21 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00582270
- Acronym / sponsor ID
- 03-012
- Conditions
- Indolent Non-Hodgkin's Lymphoma
- Keywords
- non-hodkin's lymphoma, follicular, non-follicular, infectious disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an infectious disease may be associated with the new lymphoma diagnosis.
Infections to be tested include:
- Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that has been associated with a particular kind of lymphoma, gastric MALT. We are interested to learn if the H. pylori infection may be associated with other indolent lymphomas.
- Hepatitis C: This virus infection of the liver has been found in association with non-follicular lymphomas in Italy. We want to determine if the infection is associated with lymphomas in the United States.
- Bacterial overgrowth of the small bowel: Since indolent lymphomas often affect the lymph nodes surrounding the small bowel, it may be possible that an infection within the bowel is stimulating lymphoma growth. This has never been demonstrated to date, and will be studied in this clinical study.
- Epstein-Barr virus: This is the virus that causes infectious mononucleosis or "mono." It has been associated with other rapidly growing lymphomas, but not indolent lymphoma.
Detailed description
This is a prospective observational clinical study of possible infectious disease-associated antigen drive in previously untreated patients with indolent lymphoma (follicular and nonfollicular cohorts).
Eligible patients with a new diagnosis of indolent lymphoma will be enrolled after informed consent. All patients will be tested for possible known infectious diseases that may contribute to antigen drive (H. Pylori; Hepatitis C), as well as for other infectious diseases not yet established as contributing to antigen drive (Borrelia; Chlamydia; and small bowel overgrowth). All patients will have a complete history recorded regarding other possible chronic infections, and an infectious disease consultation, as indicated.
Patients with positive antigen-drive infectious disease studies will be treated as indicated with standard antibiotic regimens and response (both infectious disease as well as lymphoma status)will be documented and recorded.
The primary objective of this study is (1) to evaluate the possible association of infectious diseases in previously untreated patients with indolent lymphoma. The secondary objective of this study is to evaluate possible lymphoma response the in patients treated for positive infectious disease studies; and to evaluate EBV immune responses in these previously untreated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Follicular Lymphoma |
| 2 | – | –Non-follicular Lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Follicular and non-follicular non-Hodgkin's lymphoma
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification2) as reviewed by a hematopathologist at Memorial Hospital.
- Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present: 1) a nodal or extranodal mass with a diameter of >7 cm, 2) involvement of at least three nodal sites [each with a diameter of >3 cm], 3) systemic symptoms, 4) plenomegaly, or 5) ureteral compression.
- No prior treatment for lymphoma is permitted.
- Karnofsky performance status > 70%
- The patient may not have a previous history of radiation therapy.
Key exclusion criteria (11 listed)
- Histologic diagnosis of intermediate grade or high grade non-Hodgkin's lymphoma.
- Histologic evidence of low grade transformation.
- Prior treatment for non-Hodgkin's lymphoma.
- Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
- GELF criteria35 for institution of systemic chemotherapy, which includes: 1) a nodal or extranodal mass with a diameter of >7 cm, 2) involvement of at least three nodal sites [each with a diameter of >3 cm], 3) systemic symptoms, 4) splenomegaly, or 5) ureteral compression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease status
Time frame: 5 years 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Portlock, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indolent Non-Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease status (time frame: 5 years 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.