CHOP/Rituximab Followed by Maintenance Pegylated Interferon-Alpha (PEG Intron)With the Treatment of Patients With Anthracycline Naïve Indolent/Follicular Non-Hodgkin's Lymphoma
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with
rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent
non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression,
molecular response, and immunologic parameters related to this treatment. Adult patients
with indolent, advanced stage, anthracycline naive NHL requiring treatment may be eligible.
Patients must have measurable disease, no severe organ dysfunction, and normal ejection
fraction in older patients. Patients also must have adequate hematologic, hepatic and renal
function, performance status, and life expectancy of at least 18 months. Patients may not
have CNS lymphoma, uncontrolled co-morbid conditions, pregnancy, HIV, and active psychiatric
conditions. Additionally, patients may not have had prior hypersensitivity to
interferon-alpha, other cancer within 5 years, significant heart disease or myocardial
infarction within the last 6 months, and history of thrombosis. Additionally, patients will
have an ocular exam prior to treatment.
Patients in this study will receive 6 cycles of combination chemotherapy with the standard
CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals
for six to eight cycles. Patients achieving at least a partial response to chemotherapy
will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be
continued for 12 months in the absence of signs of progressive/recurrent disease, or
unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on
the presence of symptoms or other clinical manifestations of toxicity. Patients will
undergo bone marrow evaluation for molecular testing at baseline. Those found to be
positive will have repeat assessments performed post induction therapy, and after six months
of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post
induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy,
patients will have disease reevaluation and then annual data collection for long-term
toxicity, duration of response and survival.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Treatment Failure/Duration of Response/Time to Treatment Failure/Survival
Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.
Robert G Bociek, MD
University of Nebraska
United States: Food and Drug Administration