Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Completed · Phase 2

Conditions studied: B-Cell Chronic Lymphocytic Leukemia

In brief

A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).

Key facts

Study ID

NCT01144260

Run by

CytRx

People needed

20

Starts

2010-06-01

Expected to finish

2013-04-01

Last updated by the study team

2013-05-15

Who can join

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

You may qualify if…

• Age ≥18 years, male or female.
• B-cell chronic lymphocytic leukemia meeting the WHO criteria.
• Relapsed or refractory disease with at least one of the following criteria: *progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin)
• progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil)
• relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent.
• Capable of providing informed consent and complying with trial procedures.
• ECOG performance status 0-2.
• Requires chemotherapy for disease as shown by any of the following criteria:
• measurable and progressive lymphocytosis
• measurable and progressive lymphadenopathy (lymph node ≥2 cm in a single diameter)
• either weight loss ≥10% within the past 6 months or extreme fatigue due to leukemia
• fevers ≥100.5 degrees F for 2 weeks with no source of infection
• night sweats with no evidence of infection
• progressive marrow failure (worsening anemia with hemoglobin <10 gm/dL and/or thrombocytopenia with platelet count <100,000/mm3)
• massive or progressive splenomegaly (spleen >6 cm below left costal margin).
• Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.]
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Accessibility to the site.

You may not qualify if…

• Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment.
• Exposure to any investigational agent within 30 days of the Screening Visit.
• Known CNS disease.
• Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
• Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1000/mm3, hematocrit level <33% for females or <35% for males.
• Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
• Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
• History or signs of active coronary artery disease with or without angina pectoris.
• Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted.
• Known HIV infection.
• Uncontrolled active, infection.
• Major surgery within 3 weeks prior to treatment.
• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UT M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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