AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

In brief

This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells

Key facts

Study ID

NCT00321724

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2006-05-01

Last updated by the study team

2013-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of B-cell chronic lymphocytic leukemia (B-CLL)
• Peripheral blood lymphocyte count > 5,000/mm³
• Small to moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes
• Bone marrow aspirate with ≥ 30% lymphoid cells
• Monoclonality of B lymphocytes by immunophenotyping, demonstrating all of the following:
• B-cell markers with CD5 antigen in the absence of other pan-T-cell markers (CD3, CD2, etc.)
• CD19 and/or CD20
• Expression of CD23 on the CLL cells OR dim B-cell expression of kappa or lambda light chains
• Disease must be refractory to or progressive after treatment with at least 1 course containing a purine nucleoside analog (e.g., fludarabine, cladribine, or pentostatin)
• Life expectancy > 6 months
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 50,000/mm³
• Hemoglobin ≥ 8 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Patients with Gilbert's syndrome may have a bilirubin ≥ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergies to compounds similar to AZD2171
• QTc prolongation < 500 msec
• No other significant ECG abnormality
• No history of familial long QT syndrome

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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