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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

interleukin-2

rituximab

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring non-hodgkins lymphoma, interleukin-2, rituximab, CD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00100737

First Posted

January 6, 2005

Last Updated

February 2, 2006

Sponsor

Chiron Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00100737

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2006

Overall Recruitment Status

Terminated

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Chiron Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

interleukin-2

Intervention Type

Drug

Intervention Name(s)

rituximab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Non-Hodgkin Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial