Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma

Inclusion Criteria:

- 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,

- 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.

Exclusion Criteria:

- 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.

- 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