CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
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.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.