Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete, Partial, and Overall Response Rates of Treatment With MTX, and Also With CY for Patients Failing to Respond to MTX

Outcome Description:

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% impr

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Thomas P. Loughran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000067089

NCT ID:

NCT00003910

Start Date:

July 1999

Completion Date:

March 2012

Related Keywords:

• Leukemia
• stage I chronic lymphocytic leukemia
• stage II chronic lymphocytic leukemia
• stage III chronic lymphocytic leukemia
• stage IV chronic lymphocytic leukemia
• T-cell large granular lymphocyte leukemia
• LGL clone
• Leukemia
• Leukemia, Lymphoid