Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin’s Lymphoma (NHL)

Non-Hodgkin Lymphoma Clinical Trial

Official title:

A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab in the Treatment of Rituximab Naïve Subjects With Follicular Non-Hodgkin’s Lymphoma, Refractory or Relapsed After Previous Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00100737
• Other study ID #: IL2NHL006
• Status: Terminated
• Phase: Phase 2
• First received: January 6, 2005
• Last updated: February 2, 2006

Study information

• Verified date: February 2006
• Source: Chiron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CD20+ follicular B-cell non-hodgkin’s lymphoma with at least 1 site of measurable disease.

• Previous treatment with 1 to 4 prior chemotherapy regimens

• ECOG performance status of greater than or equal to 2

• Life expectancy of greater than 18 weeks

• Meet safety lab requirements and organ function tests

Exclusion Criteria:

• Prior treatment with rituximab or IL-2

• Prior radioimmunotherapy including Zevalin or Bexxar

• 5 or more prior chemotherapy regimens

• Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.

• History of allogenic bone marrow transplant

• Female subjects that are pregnant or breast feeding

• Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• interleukin-2

• rituximab

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States,