- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01144260
Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
May 14, 2013 updated by: CytRx
A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells.
Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope National Medical Center
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Texas
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Houston, Texas, United States, 77030
- UT M.D. Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Bafetinib
|
250 mg orally twice daily.
Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL
Time Frame: Upto 6 months or disease progression
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Upto 6 months or disease progression
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 1 year
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
June 9, 2010
First Submitted That Met QC Criteria
June 14, 2010
First Posted (ESTIMATE)
June 15, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 14, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Bafetinib
Other Study ID Numbers
- BAFETINIB-P2-CLL-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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