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

Primary Purpose

Non-Hodgkins Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rituximab
Fludarabine
CAMPTH-1H
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Complete response rate

    Secondary Outcome Measures

    Molecular complete response rate
    Progression free survival
    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    December 29, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193466
    Brief Title
    Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bayer

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Hodgkins Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Intervention Type
    Drug
    Intervention Name(s)
    Fludarabine
    Intervention Type
    Drug
    Intervention Name(s)
    CAMPTH-1H
    Primary Outcome Measure Information:
    Title
    Complete response rate
    Secondary Outcome Measure Information:
    Title
    Molecular complete response rate
    Title
    Progression free survival
    Title
    Overall toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18189296
    Citation
    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. doi: 10.1002/cncr.23271.
    Results Reference
    result

    Learn more about this trial

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

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