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High-dose Methylprednisolone and Rituximab in High Risk B-CLL

NCT00558181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2010-02-23

No results posted yet for this study

Summary

Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.

Study Objectives

Primary:

To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.

Secondary:

To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.

Conditions

  • Chronic B-Lymphocytic Leukemia

Interventions

DRUG

rituximab, methylprednisolone

Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.

Sponsors & Collaborators

  • Vilnius University

    lead OTHER

Principal Investigators

  • Laimonas Griskevicius, PhD, MD · Vilnius University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-01-31
Completion
2009-12-31

Countries

  • Lithuania

Study Locations

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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 NCT00558181 on ClinicalTrials.gov