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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00100737

Enrollment

300

Registered

2005-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2006-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma

Keywords

non-hodgkins lymphoma, interleukin-2, rituximab, CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)

Brief 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.

Interventions

DRUGinterleukin-2

DRUGrituximab

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026