Status:
COMPLETED
Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Lead Sponsor:
CytRx
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).
Detailed Description
Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01144260
Start Date
June 1 2010
End Date
April 1 2013
Last Update
May 15 2013
Active Locations (2)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030