Chronic Lymphocytic Leukemia Clinical Trial

Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia

Summary

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.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion:

Phenotypic studies from peripheral blood showing CD3+, CD57+ cells greater than 400/mm3 or CD8+ cells greater than 650/mm3 within eight weeks prior to registration
Evidence for clonal T-cell receptor gene rearrangement within one year prior to registration
At least one of the following: Severe neutropenia less than 500/mm3, neutropenia associated with recurrent infections, symptomatic anemia, or transfusion-dependent anemia
Bilirubin ≤ 2.0 mg/dl, SGOT(AST) ≤ 1.5 times normal, and Creatinine ≤ 2.0 mg/dl within 4 weeks prior to registration
ECOG performance status of 0-2
At least 18 years of age
Written informed consent

Exclusion:

Prior therapy with oral MTX or oral Cy
Previous or concurrent malignancies except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease free for over 5 years
Pregnant or breast-feeding for female patients
Serious medical illness, other than that treated by the study, which would limit survival to less than 2 years, or psychiatric condition which would prevent informed consent

Note: to be eligible for step 2 of this study, patients were required to have no response after at least 4 months of methotrexate treatment.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

59

Study ID:

NCT00003910

Recruitment Status:

Terminated

Sponsor:

Eastern Cooperative Oncology Group

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There are 59 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

59

Study ID:

NCT00003910

Recruitment Status:

Terminated

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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