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Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia

NCT ID: NCT00162851

Last Updated: 2007-07-25

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-07-31

Brief Summary

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This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).

Detailed Description

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Conditions

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B-CLL

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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alemtuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* B-CLL that has failed fludarabine

Exclusion Criteria

* Performance status grade 3
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering Nordiska AB

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Anders C Osterborg, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Hematology, Karolinska University Hospital

Locations

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Dept. of Hematology, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CAM219

Identifier Type: -

Identifier Source: org_study_id