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Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00004857
Collaborator
National Cancer Institute (NCI) (NIH)
86
Enrollment
50
Locations
1
Arm
121
Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.

Condition or Disease Intervention/Treatment Phase
  • Biological: alemtuzumab
  • Drug: fludarabine phosphate
 Phase 2

Detailed Description

OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients.

OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Mar 1, 2003
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fludarabine + Campath-1H

Standard of care induction with fludarabine followed by consolidation antibody therapy

Biological: alemtuzumab
30 mg subQ injection tiw for 6 weeks
Other Names:
  • campath-1H

    • Drug: fludarabine phosphate
    25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13

    Outcome Measures

    Primary Outcome Measures

    1. Response [2 months post consolidation]

    Secondary Outcome Measures

    1. Toxicity [2 months post consolidation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    1. Specific Diagnosis of B-Cell CLL

    1.1 An absolute lymphocytosis of > 5,000/µl

    1.1.1 Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes.

    1.1.2 Bone marrow examination must include at least a unilateral aspirate and biopsy. The aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL. The overall cellularity must be normocellular or hypercellular.

    1.1.3 Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23, CD24) with the CD5 antigen, in the absence of other pan-T-cell markers. Additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density. Patients with bright surface immunoglobulin levels must have CD23 co-expression.

    1.2 Staging

    1.2.1 Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV) per the protocol.

    1.2.2 Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:

    • Massive or progressive splenomegaly and/or lymphadenopathy

    • Presence of weight loss > 10% over the preceding 6 month period;

    • Grade 2 or 3 fatigue

    • Fevers > 100.5°C or night sweats for greater than 2 weeks without evidence of infection

    • Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months.

    1. Prior Treatment: No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL.

    2. No medical condition requiring chronic use of oral corticosteroids.

    3. Age ≥18 years.

    4. Performance Status 0 - 2.

    5. No HIV disease. Due to alterations in host immunity, patients with HIV may not be enrolled.

    6. Non-pregnant and non-nursing. Due to the unknown teratogenic potential of Campath-1H, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.

    7. Initial Required Laboratory Values:

    Creatinine <1.5 x upper limit of institutional normal value Coomb's Testing NEGATIVE

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Affairs Medical Center - Birmingham Birmingham Alabama United States 35233-1996
    2 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    3 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
    4 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    5 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    6 Lombardi Cancer Center Washington District of Columbia United States 20007
    7 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    8 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    9 University of Illinois at Chicago Health Sciences Center Chicago Illinois United States 60612
    10 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    11 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    12 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    13 Veterans Affairs Medical Center - Togus Togus Maine United States 04330
    14 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    15 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    16 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    17 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
    18 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    19 Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri United States 65201
    20 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    21 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    22 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    23 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    24 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    25 Veterans Affairs Medical Center - Buffalo Buffalo New York United States 14215
    26 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    27 CCOP - North Shore University Hospital Manhasset New York United States 11030
    28 North Shore University Hospital Manhasset New York United States 11030
    29 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    30 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    31 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
    32 Mount Sinai Medical Center, NY New York New York United States 10029
    33 State University of New York - Upstate Medical University Syracuse New York United States 13210
    34 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
    35 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    36 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    37 Veterans Affairs Medical Center - Durham Durham North Carolina United States 27705
    38 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    39 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    40 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    41 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    42 Rhode Island Hospital Providence Rhode Island United States 02903
    43 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    44 University of Tennessee, Memphis Cancer Center Memphis Tennessee United States 38103
    45 Veterans Affairs Medical Center - Memphis Memphis Tennessee United States 38104
    46 CCOP - Southwestern Vermont Regional Cancer Center Bennington Vermont United States 05201
    47 Vermont Cancer Center Burlington Vermont United States 05401-3498
    48 Veterans Affairs Medical Center - White River Junction White River Junction Vermont United States 05009
    49 Veterans Affairs Medical Center - Richmond Richmond Virginia United States 23249
    50 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Kanti R. Rai, MD, Long Island Jewish Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00004857
    Other Study ID Numbers:
    • CALGB-19901
    • U10CA031946
    • CDR0000067506
    First Posted:
    Dec 11, 2003
    Last Update Posted:
    Jul 6, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Alliance for Clinical Trials in Oncology
    stage I chronic lymphocytic leukemia
    stage II chronic lymphocytic leukemia
    stage III chronic lymphocytic leukemia
    stage IV chronic lymphocytic leukemia
    B-cell chronic lymphocytic leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Fludarabine
    Fludarabine phosphate
    Alemtuzumab

    Study Results

    No Results Posted as of Jul 6, 2016