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Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT00161590
Collaborator
Bayer (Industry)
1
Location

Study Details

Study Description

Brief Summary

Primary Objective:
  • To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell lymphomas.
Secondary Objectives:

  • To evaluate response rate, overall survival, and disease-free survival in patients with T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy.

  • To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these lymphomas treated with the Campath + CHOP combination.

  • To determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.

Condition or Disease Intervention/Treatment Phase
  • Drug: CHOP and alemtuzumab
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas
Study Start Date :
Jul 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients must have a diagnosis of non-B-cell, non-Hodgkin's lymphoma (including T-cell, null-cell, or NK-cell lymphoma, but excluding lymphoblastic lymphoma)

    • Stage II, III, or IV disease requiring chemotherapy

    • At least one site of measurable disease, 1.5 cm in diameter or greater

    • Age > or = 18 years

    • Absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor

    • Platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor

    • Creatinine less than 2 x upper limits of normal (ULN)

    • Total bilirubin less than 2 x ULN (dose reduced vincristine and adriamycin required for bilirubin > 1.2 mg/dL)

    • Echocardiogram (Echo) or multiple gate acquisition scan (MUGA) documenting a normal ejection fraction prior to chemotherapy

    • Able to give informed consent

    Exclusion Criteria:

    • Known central nervous system (CNS) involvement

    • Known HIV disease

    • Patients who are pregnant or nursing

    • Any factor which might limit the patient's ability to provide informed consent

    • Life expectancy < 3 months

    • Patients who are unwilling to agree to use an effective means of birth control while on treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Medical College of Cornell University New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • Bayer

    Investigators

    • Principal Investigator: Richard Furman, MD, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00161590
    Other Study ID Numbers:
    • 0204-157
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Oct 22, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    NK cell lymphoma
    Null cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Alemtuzumab

    Study Results

    No Results Posted as of Oct 22, 2008