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Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT ID: NCT00193466

Last Updated: 2010-12-30

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-04-30

Brief Summary

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In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

Detailed Description

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Upon determination of eligibility, all patients will receive:

Fludarabine + Rituximab + CAMPATH-1H

Patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by CAMPATH-1H.

Conditions

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Non-Hodgkins 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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Rituximab

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

CAMPTH-1H

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

* Histologically proven B-cell CLL/SLL
* Positive staining for CD20 antigen
* No systemic chemotherapy.
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Age \> 18 years
* Life expectancy \> 12 weeks
* Adequate liver and kidney function
* Must be accessible for treatment and follow-up
* Must give written informed consent prior to entering this study.

Exclusion Criteria

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

* Female pregnant or lactating
* Unstabilized active infection on the basis of neutropenia
* History of previous severe opportunistic infections
* Serious underlying medical conditions
* Central nervous system involvement
* History of other neoplasms, either active or treated within five years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Sarah Cannon Research Institute

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

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Hainsworth JD, Vazquez ER, Spigel DR, Raefsky E, Bearden JD, Saez RA, Greco FA. Combination therapy with fludarabine and rituximab followed by alemtuzumab in the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Mar 15;112(6):1288-95. doi: 10.1002/cncr.23271.

Reference Type RESULT
PMID: 18189296 (View on PubMed)

Other Identifiers

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CAM-217

Identifier Type: -

Identifier Source: secondary_id

SCRI LYM 21

Identifier Type: -

Identifier Source: org_study_id