Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Detailed Description

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Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.

Conditions

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Non-Hodgkin Lymphoma

Keywords

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Chemotherapy and Radioimmunotherapy

CHOP-R x 3 cycles followed by zevalin and extended rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
* No prior chemotherapy
* No prior monoclonal antibody therapy
* Bulky or symptomatic disease, stage II-IV
* Performance status 0-2

Exclusion Criteria

* Impaired bone marrow reserve
* Presence of CNS lymphoma
* Serious nonmalignant disease or active infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Pittsburgh cancer Institute

Principal Investigators

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Samuel A Jacobs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.

Reference Type DERIVED

PMID: 18981007 (View on PubMed)

Other Identifiers

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UPCI #03-005

Identifier Type: -

Identifier Source: org_study_id