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Completed

NCT Number: NCT00193505

Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ifosfamide

Drug

carboplatin

Drug

etoposide

Drug

Rituximab

Drug

90Y Zevalin

Drug

Primary outcomes

  1. complete response rate

Secondary outcomes

  1. progression-free survival

  2. overall survival

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Biogen

Registry information

Official study title

Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.