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Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma


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

Thank you

Trial Information

Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma


The objective of this study is to estimate the median progression -free survival for
patients receiving this regimen, along with the rate of complete response at 6 months,
toxicities associated with this regimen, and laboratory correlates. Subjects will receive
the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and
maintenance therapy every 3 months until disease progression.


Inclusion Criteria:



- Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3

- Meeting FLIPI criteria for intermediate or high risk.

- No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;

- Patients may not have known HIV infection, and must not be Hepatitis B Surface
Antigen positive.

Exclusion Criteria:

- May not be pregnant or breastfeeding, have documented CNS disease, G-CSF or GM-CSF
within 2 weeks prior

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CT scans

Outcome Time Frame:

before and after treatment. every 3 mo after

Safety Issue:

No

Principal Investigator

Brad S Kahl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

HO04405

NCT ID:

NCT00582166

Start Date:

September 2004

Completion Date:

March 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of WisconsinMadison,, Wisconsin  53792-5666