Status:
COMPLETED
Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as ofatumumab, 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 ...
Detailed Description
OBJECTIVES: Primary * To determine the response rate in patients with previously untreated CD20-positive bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria:
- Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease
- Stage III or IV disease
- WHO grade 1, 2, or 3a disease
- Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies
- No fine-needle aspirates for diagnosis
- Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC
- At least 1 site of measurable disease that is \> 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies
- Non-measurable disease alone not allowed, including the following:
- Bone lesions (lesions if present should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by NHL should be noted)
- Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI)
- FLIPI score meeting 1 or 2 of the following risk factors:
- Age \> 60 years
- Involvement of \> 4 nodal sites
- Stage III-IV disease
- Hemoglobin \< 12.0 g/dL
- LDH normal
- Risk determined by the following:
- Low Risk: 0-1 of the above risk factors
- Intermediate Risk: 2 risk factors
- Poor Risk: ≥ 3 risk factors
- No known CNS involvement
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Creatinine clearance ≥ 30 mL/min
- Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Patients with HIV infection allowed provided the following criteria are met:
- No evidence of coinfection with hepatitis B or C
- CD4+ cell count ≥ 400/mm³
- No evidence of resistant strains of HIV
- HIV viral load \< 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load \< 50 copies if on anti-HIV therapy
- No history of AIDS-defining conditions
- No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)
- HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing
- After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required)
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL
- Prior involved-field radiation therapy allowed
- More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease
- No concurrent dexamethasone or other steroids as antiemetics
- No live virus vaccination within 6 weeks prior to study entry
- No concurrent zidvoudine or stavudine
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01190449
Start Date
August 1 2011
End Date
October 15 2020
Last Update
August 18 2021
Active Locations (48)
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1
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
2
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
3
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
4
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States, 61701