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

This study has been completed.

First Received: September 12, 2005 Last Updated: May 5, 2008 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Bayer
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193466

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

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Rituximab

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

More Information

Publications:

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
Study First Received:	September 12, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00193466 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Lymphatic Diseases

Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Fludarabine
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Fludarabine
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009