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Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Indolent Non-Hodgkin's Lymphoma

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Trial Information

Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma


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.


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 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Disease status

Outcome Time Frame:

5 years 10 months

Safety Issue:

No

Principal Investigator

Carol Portlock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

03-012

NCT ID:

NCT00582270

Start Date:

February 2003

Completion Date:

December 2013

Related Keywords:

  • Indolent Non-Hodgkin's Lymphoma
  • non-hodkin's lymphoma
  • follicular
  • non-follicular
  • infectious disease
  • Communicable Diseases
  • Infection
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021