CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): CHOP/Rituximab; PEG INTRON
Intervention type(s): Drug; Drug
Intervention description(s): Six cycles of CHOP/Rituximab therapy at 21-day intervals. CHOP chemo will be administered on day 1 after rituximab.
Cyclophosphamide750mg/m2 IV, Doxorubicin 50mg/m2 IV, Vincristine 1.4mg/m2 (max 2mg) IV, Prednisone 100mg PO daily x 5 days Rituximab 375mg/m2; Pegylated Interferon-alpha 2mg/kg/week for 52 weeks
Intervention MeSH terms: Peginterferon alfa-2b; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment