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 II

MedlinePlus related topics:   Leukemia, Adult Acute   Leukemia, Adult Chronic   Lymphoma  

ChemIDplus related topics:   Fludarabine   Fludarabine monophosphate   Rituximab   Alemtuzumab   Campath  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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)

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

Publications of Results:
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.
 

Responsible Party:   Sarah Cannon Research Institute ( John D. Hainsworth, M.D. )
Study ID Numbers:   SCRI LYM 21, CAM-217
First Received:   September 12, 2005
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00193466
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Fludarabine monophosphate
Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Fludarabine
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Antirheumatic Agents

Source: National Library of Medicine (NLM) July 08, 2008

  


 
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