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Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

NCT00201721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-08

No results posted yet for this study

Summary

This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

Conditions

  • B-Chronic Lymphocytic Leukemia

Interventions

DRUG

Pentostatin

2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.

DRUG

Rituximab

For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.

DRUG

Cyclophosphamide

600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • John Byrd · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2006-07-31
Completion
2006-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00201721 on ClinicalTrials.gov