Brief Summary

Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed

1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed

Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

3.3 years

First QC Date

November 9, 2001

Last Update Submit

August 23, 2013

Conditions

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (2)

Objective response
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner.
12 weeks
Objective response
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner.
24 weeks

Secondary Outcomes (7)

Overall response rate for MCL patients
Up to 5 years
Overall survival
From randomization to death due to any cause, assessed up to 5 years
Time to treatment failure
From randomization to the treatment-specific definition of disease progression, death, or when the patient goes off study due to refusal or toxicity, assessed up to 5 years
Complete response rate
Up to 5 years
Quality of life assessed using FACT-BRM
Baseline
+2 more secondary outcomes

Study Arms (2)

Arm I (rituximab and recombinant interleukin-12)

EXPERIMENTAL

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12 SC twice weekly beginning on day 2 and continuing until disease progression.

Biological: rituximabBiological: recombinant interleukin-12Other: laboratory biomarker analysisOther: questionnaire administrationProcedure: quality-of-life assessment

Arm II (rituximab and recombinant interleukin-12)

EXPERIMENTAL

Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression.

Biological: rituximabBiological: recombinant interleukin-12Other: laboratory biomarker analysisOther: questionnaire administrationProcedure: quality-of-life assessment