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

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ClinicalTrials.gov Identifier: NCT00100737
Recruitment Status : Terminated
First Posted : January 7, 2005
Last Update Posted : February 6, 2006
Information provided by:
Chiron Corporation

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: interleukin-2 Drug: rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100737

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

ClinicalTrials.gov Identifier: NCT00100737     History of Changes
Other Study ID Numbers: IL2NHL006
First Posted: January 7, 2005    Key Record Dates
Last Update Posted: February 6, 2006
Last Verified: February 2006

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents