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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Study of LMB-2 Immunotoxin in Patients With CD25-Positive Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI	NCI-04-C-0121 NCI-6074, 6074, NCT00080821

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Trial Description

Purpose:

LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. This may be effective treatment for chronic lymphocytic leukemia or prolymphocytic leukemia.

This phase II trial is studying how well LMB-2 immunotoxin works in treating patients with chronic lymphocytic leukemia or prolymphocytic leukemia.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Progressive cancer within 2 years after receiving fludarabine
• More than 1 month since monoclonal antibody therapy
• No previous LMB-2 immunotoxin
• More than 4 weeks since chemotherapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of LMB-2 immunotoxin on days 1, 3, and 5. Treatment may be repeated every 4 weeks for up to six courses. Some patients may receive additional LMB-2 immunotoxin. Patients will be evaluated every 3-12 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Robert Kreitman, MD, Protocol chair		Ph: 301-496-6947 Email: kreitmar@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Chronic Lymphocytic Leukemia
Trial Start Date		2004-02-09
Trial Completion Date		2005-03-20 (estimated)
Registered in ClinicalTrials.gov		NCT00080821
Date Submitted to PDQ		2004-02-09
Information Last Verified		2008-05-20

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