Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia
3 other identifiers
interventional
59
1 country
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 leukemia
Started Sep 1999
Longer than P75 for phase_2 leukemia
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 27, 2013
CompletedJuly 5, 2023
June 1, 2023
11.2 years
November 1, 1999
October 16, 2012
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Complete or Partial Response to Treatment With MTX
We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count \> 1500/mm3, lymphocyte count\< 4000/mm3, hemoglobin \> 11 g/dl, and platelet count \> 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement.
Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.
Secondary Outcomes (1)
Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX
Assessed during the first 4 months of treatment and followed until reaching full study stop date
Study Arms (1)
Methotrexate (Cy if no response to MTX)
EXPERIMENTALMTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
Interventions
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.
Initial treatment consisted of MTX given orally at 10 mg/m2 in divided doses once weekly.
Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, 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, 80224-2522, 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, 60611-3013, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781, 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, 21231-2410, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, 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, 55422-2900, 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, 44710-1799, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, 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, 19111-2497, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Thomas P. Loughran, MD
Milton S. Hershey Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
September 15, 1999
Primary Completion
December 1, 2010
Study Completion
March 1, 2012
Last Updated
July 5, 2023
Results First Posted
May 27, 2013
Record last verified: 2023-06