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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193466
First received: September 12, 2005
Last updated: December 29, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkins Lymphoma
 Drug: Rituximab
Drug: Fludarabine
Drug: CAMPTH-1H
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Complete response rate

Secondary Outcome Measures:
  • Molecular complete response rate
  • Progression free survival
  • Overall toxicity

Estimated Enrollment: 40
Study Start Date: January 2002
Study Completion Date: April 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193466

Sponsors and Collaborators
Sarah Cannon Research Institute
Bayer
Investigators
Principal Investigator: John D. Hainsworth, MD Sarah Cannon Research Institute
  More Information

Additional Information:
Published in Cancer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: John D. Hainsworth, M.D., Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193466     History of Changes
Other Study ID Numbers: SCRI LYM 21, CAM-217
Study First Received: September 12, 2005
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
 Fludarabine monophosphate
Alemtuzumab
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013