Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT00994643
Phase
PHASE2
Status
Completed

Conditions

  • High Risk Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Given IV
  • Interleukin-2 — BIOLOGICAL
    Given SC

Study Details

This is a study to see if maintenance therapy with low dose interleukin-2 (IL-2) and rituximab can delay or prevent recurrences in patients with high risk Non-Hodgkin's Lymphoma (NHL). IL-2 is a naturally occurring cytokine in our immune system which may enhance the activity of a known therapeutic agent rituximab, a monoclonal antibody against CD-20, in the setting of NHL.

Key Dates

Start date
Feb 5, 2009
Status verified
Apr 2025
Primary completion
Jun 25, 2014
Completion
Jun 25, 2015

Study Design

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

Arms

  • Experimental: Treatment (Interleukin Therapy, Monoclonal Antibody)
    Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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