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Status:

COMPLETED

Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia

Lead Sponsor:

German CLL Study Group

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief Summary

RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating fac...

Detailed Description

OBJECTIVES: Primary * Determine the safety and feasibility of cytoreductive fludarabine and cyclophosphamide followed by high-dose myeloablative therapy comprising total-body irradiation, cyclophosp...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Chronic lymphocytic leukemia (CLL), meeting 1 of the following stage criteria:
  • Stage I-IV disease
  • Binet stage B or C disease
  • Binet stage A disease at high risk for rapid disease progression, as defined by both of the following criteria:
  • Nonnodular marrow infiltration and/or lymphocyte doubling time \< 12 months
  • Thymidine kinase \> 7.0 U/L and/or ß-2-microglobulin \> 3.5 mg/L
  • Polymerase chain reaction-amplifiable clonal CDR III rearrangement of the immunoglobulin variable heavy chain gene
  • No Richter's syndrome or B-prolymphocytic leukemia
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • No concurrent disease resulting in major organ dysfunction
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other concurrent malignancy
  • No New York Heart Association class III or IV cardiac failure
  • No cardiomyopathy
  • No history of myocardial infarction
  • No symptomatic coronary heart disease
  • No severe cardiac arrhythmia
  • No severe or uncontrolled hypertension
  • No chronic pulmonary disease
  • No pulmonary function test impairment
  • No severe or uncontrolled diabetes mellitus
  • Bilirubin or transaminases ≤ 1.5 times upper limit of normal
  • Creatinine ≤ 1.4 mg/dL
  • No cerebral dysfunction
  • No severe psychiatric impairment
  • No drug addiction or alcoholism
  • Negative HIV
  • Negative Hepatitis B or C
  • No allergy to any of the protocol drugs
  • No history of anaphylactic reaction to monoclonal antibodies
  • No active infection
  • PRIOR CONCURRENT THERAPY:
  • No more than 1 prior chemotherapy regimen OR chemotherapy that lasted \> 6 months
  • No prior radiotherapy
  • No prior treatment with alemtuzumab
  • No prior long-term (\> 1 month) systemic corticosteroids
  • No prior therapy with dexamethasone, carmustine, etoposide, cytarabine, and melphalan (Dexa-BEAM)

Exclusion

    Key Trial Info

    Start Date :

    June 1 2001

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2004

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00276809

    Start Date

    June 1 2001

    End Date

    September 1 2004

    Last Update

    September 26 2016

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, Germany, D-12200

    2

    Universitaetsklinikum Essen

    Essen, Germany, D-45122

    3

    Asklepios Klinik St. Georg

    Hamburg, Germany, D-20099

    4

    Medizinische Hochschule Hannover

    Hanover, Germany, D-30625