NCT00100737

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.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2005

Completed
Last Updated

February 6, 2006

Status Verified

February 1, 2006

First QC Date

January 6, 2005

Last Update Submit

February 2, 2006

Conditions

Non-Hodgkin Lymphoma

Keywords

non-hodgkins lymphomainterleukin-2rituximabCD20+ follicular B-cell non-hodgkins lymphoma (grade I, II,III)

Interventions

interleukin-2DRUG
rituximabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior treatment with rituximab or IL-2
  • Prior radioimmunotherapy including Zevalin or Bexxar
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Follicular

Interventions

Interleukin-2Rituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 6, 2005

First Posted

January 7, 2005

Last Updated

February 6, 2006

Record last verified: 2006-02

Locations

US(1)