Phase 2
N=59
Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00553501 ↗Enrolled (actual)
59
Serious AEs
17.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants With Overall Response — 25; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- epratuzumab (Biological); rituximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Response |
25; 27 | — |
| SECONDARY Progression Free Survival |
3.5 | — |
Summary
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)
- Previously untreated disease
- WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis
- Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
- Measurable disease by physical examination or imaging studies
- Any tumor mass > 1 cm is acceptable
- No nonmeasurable disease only, including any of the following:
- Bone lesions
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by NHL should be noted)
- No known CNS involvement by lymphoma
- Required to participate in companion FDG-PET imaging study CALGB 580701
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 2
- Absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 50,000/μL
- Patients with HIV infection are eligible provided they meet the following criteria:
- No evidence of coinfection with hepatitis B or C
- CD4+ cell count ≥ 400/mm^3
- No evidence of resistant strains of HIV
- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL
- If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
- No history of AIDS-defining conditions
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- No known Human Anti-Chimeric Antibody (HACA)-positivity
PRIOR CONCURRENT THERAPY:
- No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
- More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease
- No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
- Treatment of acute infusion reactions according to institutional procedures
- No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
- No other concurrent chemotherapeutic agents
Data sourced from ClinicalTrials.gov (NCT00553501). 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.