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Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193505
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011

September 12, 2005
May 2, 2011
October 2003
August 2005   (final data collection date for primary outcome measure)
complete response rate
Same as current
Complete list of historical versions of study NCT00193505 on ClinicalTrials.gov Archive Site
  • progression-free survival
  • overall survival
Same as current
Not Provided
Not Provided
 
Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Upon determination of eligibility, patients will receive:

  • Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkins Lymphoma
  • Drug: Ifosfamide
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Rituximab
  • Drug: 90Y Zevalin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
  • Persistent lymphoma after one or two previous chemotherapy regimens
  • Patients should not be considered candidates for high-dose chemotherapy
  • Ability to perform activities of daily living with assistance
  • Measurable or evaluable disease
  • Age > 18 years
  • Adequate bone marrow, liver and kidney function

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Patients with impaired bone marrow reserve
  • Female patients who are pregnant or lactating
  • Serious active infection at the time of treatment
  • Any other serious underlying condition
  • Brain or meningeal) with lymphoma
  • HIV or AIDS-related lymphoma
  • Received external beam radiation therapy to > 25% of active bone marrow.
  • History of other cancers, either active or treated

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00193505
SCRI LYM 27, 106-P092
No
John Hainsworth, MD, Sarah Cannon Research Institute
SCRI Development Innovations, LLC
Biogen Idec
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP