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Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

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Trial Conditions
  • Lymphoma
What is the purpose of this trial?

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:

- Follicular grade 1 or 2

- Small lymphocytic

- Marginal zone (nodal)

- Marginal zone (splenic)

- Mucosa-associated lymphoid tissue (MALT)

- No evidence of transformation to a large cell histology

- Stage III or IV disease

- Must meet the following criteria for low tumor burden:

- No nodal or extranodal mass at least 7 cm

- Less than 3 nodal masses greater than 3 cm in diameter

- No systemic symptoms or B symptoms

- No splenomegaly greater than 16 cm by CT scan

- No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)

- No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes

- No cytopenias, defined as any of the following:

- Platelet count less than 100,000/mm^3

- Hemoglobin less than 10 g/dL

- Absolute neutrophil count less than 1,500/mm^3

- At least 1 objective measurable disease parameter

- Abnormal PET scans will not constitute evaluable disease unless verified by CT
scan or other appropriate imaging

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3*

- Hemoglobin at least 10 g/dL*

- Platelet count at least 100,000/mm^3* NOTE: *Without growth factor and/or transfusion
support

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin
normal for patients with Gilbert's Syndrome

- AST/ALT no greater than 5 times ULN

- Hepatitis B surface antigen negative

Renal

- Creatinine no greater than 2 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No uncontrolled active infection

- Afebrile for at least 48 hours off antibiotics

- No other malignancy within the past 2 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Radiotherapy

- No prior immunotherapy for lymphoma

Chemotherapy

- No prior chemotherapy for lymphoma

- No concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for lymphoma

- No concurrent radiotherapy

- No concurrent radioimmunotherapy

Surgery

- Not specified

Gender: Both
Steward Physician(s)
  • Brad S. Kahl, MD
Facilities
  • Morton Hospital - Active, not recruiting
Trial Interventions
Biological
  • rituximab
Physician Researcher

Investigator Name:

  • Brad S. Kahl, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00075946
Volunteers:  Not Accepting Healthy Volunteers

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