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A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Phase 2
18 Years
Not Enrolling
B-Cell Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

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.

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

- either weight loss ≥10% within the past 6 months or extreme fatigue due to

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL

Outcome Time Frame:

Upto 6 months or disease progression

Safety Issue:


Principal Investigator

Daniel Levitt, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

April 2013

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • CLL
  • leukemia
  • chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



City of Hope National Medical Center Los Angeles, California  91010
UT M.D. Anderson Cancer Center Houston, Texas  77030