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.
Sponsor:
Information provided by:
Chiron Corporation
ClinicalTrials.gov Identifier:
NCT00100737
First received: January 6, 2005
Last updated: February 2, 2006
Last verified: February 2006
  Purpose

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
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100737

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

No publications provided

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014