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Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Active Not specified Pharmaceutical / Industry C07-003
NCT00648739

Trial Description

Summary

The purpose of this study is to determine the safety and best dose of ALXN6000 in treating relapsing or refractory B-CLL and to study how ALXN6000 may help the immune system fight cancer.

Eligibility Criteria

Inclusion Criteria:

Relapsing or Refractory B CLL

ECOG performance status 0-2

Anticipated survival of greater than 6 months.

Female patients of childbearing potential must agree to use two forms of contraception

Must have an indication for treatment of B CLL such as anemia, thrombocytopenia, symptomatic lymphadenopathy or other standard indication.

Is willing and able to give written informed consent.

Exclusion Criteria:

Absolute neutrophil count (ANC) < 1000 x 109/L

Platelet count < 50,000 x 109/L

Pregnant or lactating women.

Prior history of autoimmune hemolysis requiring therapy.

Prior history of immune thrombocytopenia.

Active autoimmune disease requiring immunosuppressive therapy.

Positive Coombs' Test.

Ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.

Prior allogeneic stem cell transplantation.

Prior therapy for B CLL within 30 days of enrollment.

Neurosurgery or cranial radiation therapy within one year of enrollment.

Trial Contact Information

Trial Lead Organizations/Sponsors

Alexion Pharmaceuticals, Incorporated

Maria Whelden		Ph: 203-271-8181
		Email: wheldenm@alxn.com

Trial Sites

U.S.A.

Arizona

Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

New Jersey

Morristown

Hematology Oncology Assoc. of Northern NJ Carol G. Simon Cancer Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00648739
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.