Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment ofatumumab
Phase phase 2
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date August 2011
End date June 2017
Trial size 100 participants
Trial identifier NCT01190449, CALGB-50901, CDR0000683083, GSK-CALGB-50901

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 or carry cancer-killing substances to them.

PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
ofatumumab
Given IV
(Experimental)
Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
ofatumumab
Given IV

Primary Outcomes

Measure
Overall response (complete or partial response)
time frame: Up to 10 years

Secondary Outcomes

Measure
Progression-free survival
time frame: Up to 10 years
Comparison of two ofatumumab doses efficacy with historical controls
time frame: Up to 10 years
Comparison of two ofatumumab doses toxicity with historical controls
time frame: Up to 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Principal investigator Cara A. Rosenbaum, MD
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- or high-dose of ofatumumab. Secondary - To determine the progression-free survival (PFS) of patients treated with these regimens. - To determine the toxicity profile of these regimens in these patients. - To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic doublet trials. - To evaluate the two ofatumumab doses by independent comparison of response, PFS, and toxicity to a historical control in previously untreated patients with follicular NHL. - To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk patients and compare to low- and intermediate-risk stratified patients by standard FLIPI scoring to determine a more reliable indicator of response and PFS. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9. - Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients may undergo blood and bone marrow sample collection for correlative studies. After completion of study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 8 years.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.