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A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

NCT ID: NCT00858117

Last Updated: 2020-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-26

Study Completion Date

2013-01-24

Brief Summary

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RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving alemtuzumab together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Detailed Description

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OBJECTIVES:

* To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab.
* To evaluate the toxicity of alemtuzumab and rituximab in these patients.

OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20, CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.

After completion of study treatment, patients are followed periodically for 5 years.

Conditions

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Leukemia

Keywords

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B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alemtuzumab and Rituximab

Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type BIOLOGICAL

Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks

Rituximab

Intervention Type BIOLOGICAL

Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks

Interventions

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Alemtuzumab

Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks

Intervention Type BIOLOGICAL

Rituximab

Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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Campath-1H Rituxan

Eligibility Criteria

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Inclusion Criteria

PRIOR CONCURRENT THERAPY:

* Prior corticosteroid therapy allowed
* No prior cytotoxic therapy (other than corticosteroids)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga Frankfurt, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU 04H6

Identifier Type: OTHER

Identifier Source: secondary_id

STU00004494

Identifier Type: OTHER

Identifier Source: secondary_id

NU 04H6

Identifier Type: -

Identifier Source: org_study_id