Phase 3
Completed N=545
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00075946 ↗Enrolled (actual)
545
Serious AEs
4.5%
Results posted
Jun 2015
Primary outcomePrimary: Time to Rituximab Failure (TTRF) — 3.92; 4.32; 1.39; 4.83 years — p=0.33
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Rituximab Failure (TTRF) |
3.92; 4.32; 1.39; 4.83 | 0.33 |
| SECONDARY Time to First Cytotoxic Therapy (TTFC) |
0.84; 0.95; 0.72; 1 | 0.002 sig |
| SECONDARY Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization |
1.04; -0.71 | 0.270 |
Eligibility Criteria
INCLUSION CRITERIA
- 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)
- 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 a computed tomography (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 positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging
- Age: 18 and over
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Must meet the following criteria for labs:
- Hematopoietic
- 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
- The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN
- Hepatitis B surface antigen negative
- Renal
- Creatinine no greater than 2 times ULN
EXCLUSION CRITERIA
- Evidence of transformation to a large cell histology
- Pregnant or nursing. Fertile patients must use effective contraception
- HIV positive
- Uncontrolled active infection
- 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 immunotherapy for lymphoma
- Prior chemotherapy for lymphoma
- Concurrent chemotherapy
- Prior radiotherapy for lymphoma
- Concurrent radiotherapy
- Concurrent radioimmunotherapy
Data sourced from ClinicalTrials.gov (NCT00075946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.