LymphomaNCT00461084
Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma
An observational study of Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- BIAXIN (CLARITHROMYCIN)
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 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: Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC
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 classification1) 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:
- A nodal or extranodal mass with a diameter of >7 cm,
- Involvement of at least three nodal sites [each with a diameter of >3 cm],
- Systemic symptoms,
- Symptomatic splenomegaly,
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- Ureteral compression.
- No prior treatment for lymphoma is permitted.
- Measurable disease is required.
- 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
- Allergy to biaxin (clarithromycin), erythromycin, or other macrolide antibiotic. Patients requiring use of ergot derivatives, pimozide, cisapride, or astemizole; combination with ranitidine bismuth citrate should not be used in patients with history of acute porphyria or CrCl <25 mL/minute.
- Prior treatment with Biaxin (clarithromycin) during the prior 6 months.
- Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.
- Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.
- Prior treatment for non-Hodgkin's lymphoma.
- Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
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- GELF criteria21 for institution of systemic chemotherapy, which includes:
- A nodal or extranodal mass with a diameter of >7 cm,
- Involvement of at least three nodal sites [each with a diameter of >3 cm],
- Systemic symptoms,
- Symptomatic splenomegaly,
- Ureteral compression.
- Patients with a known history of HIV, Hepatitis B or C seropositivity.
- Patients who require therapy with systemic corticosteroids.
- 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.
- Pregnant or lactating women, since imaging cannot be done in this setting.18
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
Official title: Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma
The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.
Read the detailed description
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,). This is the primary objective Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression:
Response rate (CR + PR) according to H. pylori positive or negative (RR with a confidence interval will be estimated for each subset). Immunohistochemistry in all diagnostic biopsy specimens: Lymphocyte- Activated Macrophage (CD68) and other selected markers to clarify tumor infiltrating cells. Peripheral blood mononuclear cell (PBMCs) studies to evaluate possible HDAC (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.
- Conditions
- Lymphoma
- Being tested
- BIAXIN (CLARITHROMYCIN)
- Keywords
- Lymphoma, Advanced Stage, Untreated, Advanced Stage Lymphoma, Untreated Lymphoma, 07-038
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIAXIN (CLARITHROMYCIN)Drug
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
Biaxin (clarithromycin)Drug
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
| Study group | Role | What they receive |
|---|---|---|
| 1 | lymphoma follicular Receives: Drug: BIAXIN (CLARITHROMYCIN) | |
| 2 | lymphoma non-follicular Receives: Drug: Biaxin (clarithromycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,).
Measured: conclusion of study
Secondary outcomes (1)
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 36 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
- NCT00461084
- Sponsor's protocol ID
- 07-038
- Status last verified
- Sep 2014
- First submitted
- 13 Apr 2007
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Portlock CS, Hamlin PA, Gerecitano JF, Noy A, Palomba ML, Walkley J, Corcoran S, Migliacci J, Schoder H, Papanicolaou G, Markowitz AJ. A Positive Prospective Trial of Antibiotic Therapy in Advanced Stage, Non-Bulky Indolent Lymphoma. Tumor Microenviron Ther. 2015 Feb;2(1):14-18. doi: 10.1515/tumor-2015-0001. Epub 2015 Feb 18.
PubMed 26798624
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00461084
- Acronym / sponsor ID
- 07-038
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Advanced Stage, Untreated, Advanced Stage Lymphoma, Untreated Lymphoma, 07-038
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Apr 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 see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.
Detailed description
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,). This is the primary objective Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression:
Response rate (CR + PR) according to H. pylori positive or negative (RR with a confidence interval will be estimated for each subset). Immunohistochemistry in all diagnostic biopsy specimens: Lymphocyte- Activated Macrophage (CD68) and other selected markers to clarify tumor infiltrating cells. Peripheral blood mononuclear cell (PBMCs) studies to evaluate possible HDAC (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: BIAXIN (CLARITHROMYCIN)lymphoma follicular |
| 2 | – | Drug: Biaxin (clarithromycin)lymphoma non-follicular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC
Key inclusion criteria (13 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 classification1) 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:
Key exclusion criteria (16 listed)
- Allergy to biaxin (clarithromycin), erythromycin, or other macrolide antibiotic. Patients requiring use of ergot derivatives, pimozide, cisapride, or astemizole; combination with ranitidine bismuth citrate should not be used in patients with history of acute porphyria or CrCl <25 mL/minute.
- Prior treatment with Biaxin (clarithromycin) during the prior 6 months.
- Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.
- Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.
- Prior treatment for non-Hodgkin's lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIAXIN (CLARITHROMYCIN)Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present. | Drug | 1 |
| Biaxin (clarithromycin)Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present. | Drug | 2 |
Primary outcome
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,).
Time frame: conclusion of study
1 secondary outcome
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression
Time frame: conclusion of study
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 18 Sep 2014.
- Derived from this study: PubMed 26798624Portlock CS, Hamlin PA, Gerecitano JF, Noy A, Palomba ML, Walkley J, Corcoran S, Migliacci J, Schoder H, Papanicolaou G, Markowitz AJ. A Positive Prospective Trial of Antibiotic Therapy in Advanced Stage, Non-Bulky Indolent Lymphoma. Tumor Microenviron Ther. 2015 Feb;2(1):14-18. doi: 10.1515/tumor-2015-0001. Epub 2015 Feb 18.
- 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 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 13 inclusion and 16 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 18 Sep 2014. 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?
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,). (time frame: conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461084, which also lists 1 linked publication.
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 18 Sep 2014.