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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT01144260
First received: June 9, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Drug: bafetinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Resource links provided by NLM:


Further study details as provided by CytRx:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: April 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bafetinib Drug: bafetinib
250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.
Other Name: INNO-406

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144260

Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Texas
UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
CytRx
Investigators
Study Director: Daniel Levitt, M.D., Ph.D. CytRx
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT01144260     History of Changes
Other Study ID Numbers: BAFETINIB-P2-CLL-01
Study First Received: June 9, 2010
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
CLL
leukemia
chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014