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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193466
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 30, 2010
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Drug: Rituximab Drug: Fludarabine Drug: CAMPTH-1H Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Study Start Date : January 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2008

Primary Outcome Measures :
  1. Complete response rate

Secondary Outcome Measures :
  1. Molecular complete response rate
  2. Progression free survival
  3. Overall toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193466

Sponsors and Collaborators
SCRI Development Innovations, LLC
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Publications of Results:
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Responsible Party: John D. Hainsworth, M.D., Sarah Cannon Research Institute Identifier: NCT00193466     History of Changes
Other Study ID Numbers: SCRI LYM 21
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 30, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents