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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00193505
Enrollment
40
Registered
2005-09-19
Start date
2003-10-31
Completion date
2005-08-31
Last updated
2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkins Lymphoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGIfosfamide
DRUGCarboplatin
DRUGEtoposide
DRUGRituximab

Sponsors

Biogen
CollaboratorINDUSTRY
SCRI Development Innovations, LLC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
complete response rate

Secondary

MeasureTime frame
progression-free survival
overall survival

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026