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Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

NCT00071396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-08-07

Study results available
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Summary

The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Conditions

Interventions

DRUG

Campath-1H

15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.

DRUG

Rituximab

375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Alessandra Ferrajoli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-09-30
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00071396 on ClinicalTrials.gov