CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT00574730
Status
Completed

Conditions

  • Non-Hodgkins Lymphoma

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CHOP/Rituximab — DRUG
    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
  • PEG INTRON — DRUG
    Pegylated Interferon-alpha 2mg/kg/week for 52 weeks

Study Details

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.

Key Dates

Start date
May 23, 2001
Status verified
Sep 2023
Primary completion
Aug 1, 2005
Completion
Jun 7, 2012

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants 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. Participants 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.

Primary Outcome Measure

Time to Treatment Failure/Duration of Response/Time to Treatment Failure/Survival [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Nebraska Medical CenterOmahaNebraska68198-

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By research site
Unversity of Nebraska Medical Center· Omaha, NE

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