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

This study has been terminated.
Information provided by:
Chiron Corporation Identifier:
First received: January 6, 2005
Last updated: February 2, 2006
Last verified: February 2006

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.

Condition Intervention Phase
Non-Hodgkin Lymphoma
Drug: interleukin-2
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Chiron Corporation:

Estimated Enrollment: 300

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00100737

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Chiron Corporation
  More Information

No publications provided Identifier: NCT00100737     History of Changes
Other Study ID Numbers: IL2NHL006
Study First Received: January 6, 2005
Last Updated: February 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Chiron Corporation:
non-hodgkins lymphoma
CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Immunologic Factors
Antirheumatic Agents processed this record on April 17, 2014