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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

IL2NHL006

NCT ID:

NCT00100737

Start Date:

Completion Date:

Related Keywords:

  • Non-Hodgkin Lymphoma
  • non-hodgkins lymphoma
  • interleukin-2
  • rituximab
  • CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263