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A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia (NCT00003910)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of methotrexate with or without cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or anemia.
  • Drug: Cyclophosphamide
    Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule. In patients showing a partial response, but not a CR, the maximum period of therapy was 1 year.
    • Drug: Methotrexate
      Initial treatment consisted of MTX given orally at 10 mg/m2 in divided doses once weekly.
      • Drug: Prednisone
        Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days.
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        LGL leukemia is characterized by clonal expansion of cytotoxic T cells. Prominent clinical features include neutropenia, anemia, and rheumatoid arthritis. The terminal effector memory phenotype (CD3+/CD8+/CD57+/CD45RA+/CD62L-) of leukemic LGL suggest a pivotal chronic antigen driven immune response. LGL survival is then promoted by PDGF and IL-15, resulting in global dysregulation of apoptosis and resistance to normal pathways of activation-induced death. These pathogenic features explain why treatment of LGL leukemia is based on immunosuppression therapy. However, no standard therapy has been established due to the absence of large prospective trials.

        Oral low dose MTX has been shown to be efficacious in the treatment of neutropenia. However, response to MTX is slow, requiring several months for the neutrophil count to increase above 500/mm3. Also, complete clinical remission may not be achieved until after one year of MTX therapy. Oral Cy has been the primary drug used for the treatment of severe transfusion-dependent anemia. Beneficial clinical effects are seen despite this treatment having no apparent effect on the abnormal LGL clone. Normal hematocrits are maintained after cessation of Cy and these results contrast the effects seen with MTX, in which clinical remissions are often associated with the disappearance of the clone.

        This phase II trial undertaken by the Eastern Cooperative Group (ECOG) was initiated to investigate the mechanism of treatment response in patients with LGL leukemia, who need treatment for anemia or neutropenia.

        68 locations

        United States (68)
        • Aurora Presbyterian Hospital
          Aurora, Colorado, United States, 80012
        • Boulder Community Hospital
          Boulder, Colorado, United States, 80301-9019
        • Penrose Cancer Center at Penrose Hospital
          Colorado Springs, Colorado, United States, 80933
        • St. Anthony Central Hospital
          Denver, Colorado, United States, 80204
        • Porter Adventist Hospital
          Denver, Colorado, United States, 80210
        • Presbyterian - St. Luke's Medical Center
          Denver, Colorado, United States, 80218
        • St. Joseph Hospital
          Denver, Colorado, United States, 80218
        • Rose Medical Center
          Denver, Colorado, United States, 80220
        • CCOP - Colorado Cancer Research Program
          Denver, Colorado, United States, 80224-2522
        • Swedish Medical Center
          Englewood, Colorado, United States, 80110
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
          Grand Junction, Colorado, United States, 81502
        • North Colorado Medical Center
          Greeley, Colorado, United States, 80631
        • Sky Ridge Medical Center
          Lone Tree, Colorado, United States, 80124
        • Hope Cancer Care Center at Longmont United Hospital
          Longmont, Colorado, United States, 80501
        • McKee Medical Center
          Loveland, Colorado, United States, 80539
        • St. Mary - Corwin Regional Medical Center
          Pueblo, Colorado, United States, 81004
        • North Suburban Medical Center
          Thornton, Colorado, United States, 80229
        • Exempla Lutheran Medical Center
          Wheat Ridge, Colorado, United States, 80033
        • Medical Center of Central Georgia
          Macon, Georgia, United States, 31208
        • Rush-Copley Cancer Care Center
          Aurora, Illinois, United States, 60504
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
          Chicago, Illinois, United States, 60611-3013
        • Evanston Northwestern Healthcare - Evanston Hospital
          Evanston, Illinois, United States, 60201-1781
        • Joliet Oncology-Hematology Associates, Limited - West
          Joliet, Illinois, United States, 60435
        • North Shore Oncology and Hematology Associates, Limited - Libertyville
          Libertyville, Illinois, United States, 60048
        • Carle Cancer Center at Carle Foundation Hospital
          Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
          Urbana, Illinois, United States, 61801
        • Methodist Cancer Center at Methodist Hospital
          Indianapolis, Indiana, United States, 46202
        • Saint Anthony Memorial Health Centers
          Michigan City, Indiana, United States, 46360
        • McFarland Clinic, PC
          Ames, Iowa, United States, 50010
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
          Mason City, Iowa, United States, 50401
        • Siouxland Hematology-Oncology Associates, LLP
          Sioux City, Iowa, United States, 51101
        • Mercy Medical Center - Sioux City
          Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
          Sioux City, Iowa, United States, 51104
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
          Baltimore, Maryland, United States, 21231-2410
        • Borgess Medical Center
          Kalamazoo, Michigan, United States, 49001
        • West Michigan Cancer Center
          Kalamazoo, Michigan, United States, 49007-3731
        • Bronson Methodist Hospital
          Kalamazoo, Michigan, United States, 49007
        • Fairview Ridges Hospital
          Burnsville, Minnesota, United States, 55337
        • Mercy and Unity Cancer Center at Mercy Hospital
          Coon Rapids, Minnesota, United States, 55433
        • Fairview Southdale Hospital
          Edina, Minnesota, United States, 55435
        • Mercy and Unity Cancer Center at Unity Hospital
          Fridley, Minnesota, United States, 55432
        • Hutchinson Area Health Care
          Hutchinson, Minnesota, United States, 55350
        • Meeker County Memorial Hospital
          Lichfield, Minnesota, United States, 55355
        • HealthEast Cancer Care at St. John's Hospital
          Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
          Maplewood, Minnesota, United States, 55109
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
          Minneapolis, Minnesota, United States, 55407
        • Hennepin County Medical Center - Minneapolis
          Minneapolis, Minnesota, United States, 55415
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
          Robbinsdale, Minnesota, United States, 55422-2900
        • CCOP - Metro-Minnesota
          Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
          Saint Louis Park, Minnesota, United States, 55416
        • HealthEast Cancer Care at St. Joseph's Hospital
          Saint Paul, Minnesota, United States, 55102
        • United Hospital
          Saint Paul, Minnesota, United States, 55102
        • St. Francis Cancer Center at St. Francis Medical Center
          Shakopee, Minnesota, United States, 55379
        • Regions Hospital Cancer Care Center
          St. Paul, Minnesota, United States, 55101
        • Ridgeview Medical Center
          Waconia, Minnesota, United States, 55387
        • HealthEast Cancer Care at Woodwinds Health Campus
          Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
          Woodbury, Minnesota, United States, 55125
        • Aultman Cancer Center at Aultman Hospital
          Canton, Ohio, United States, 44710-1799
        • St. Rita's Medical Center
          Lima, Ohio, United States, 45801
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
          Hershey, Pennsylvania, United States, 17033-0850
        • Central Pennsylvania Hematology and Medical Oncology Associates, PC
          Lemoyne, Pennsylvania, United States, 17043
        • Lewistown Hospital
          Lewistown, Pennsylvania, United States, 17044
        • Fox Chase Cancer Center - Philadelphia
          Philadelphia, Pennsylvania, United States, 19111-2497
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
          Reading, Pennsylvania, United States, 19612-6052
        • Mount Nittany Medical Center
          State College, Pennsylvania, United States, 16803
        • Gundersen Lutheran Center for Cancer and Blood
          La Crosse, Wisconsin, United States, 54601
        • Froedtert Hospital and Medical College of Wisconsin
          Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center
          Milwaukee, Wisconsin, United States, 53226
        Participant Flow: Overall Study
        Methotrexate
        Cyclophosphomide
        Serious Adverse Events
        Methotrexate
        Cyclophosphamide
        Other Adverse Events
        Methotrexate
        Cyclophosphamide
        Status:
        terminated
        Type:
        Interventional
        Phase:
        Start:
        30 June, 1999
        Updated:
        05 October, 2015
        Participants:
        59
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