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

NCT00574730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

  • Non-Hodgkins Lymphoma

Interventions

DRUG

CHOP/Rituximab

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

DRUG

PEG INTRON

Pegylated Interferon-alpha 2mg/kg/week for 52 weeks

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Robert G Bociek, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-23
Primary Completion
2005-08-01
Completion
2012-06-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574730 on ClinicalTrials.gov