MedTrace Logo

Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia

NCT00003910 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-07-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Thomas P. Loughran, MD · Milton S. Hershey Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-15
Primary Completion
2010-12-01
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003910 on ClinicalTrials.gov