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

NCT01144260 | Completed Phase 2

• 1 other identifier: BAFETINIB-P2-CLL-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

CLL; leukemia; chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

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

  Upto 6 months or disease progression

Secondary Outcomes (1)

• Adverse Events

  1 year

Study Arms (1)

Bafetinib

EXPERIMENTAL

Drug: bafetinib

Interventions

bafetinib DRUG

250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.

Also known as: INNO-406

Bafetinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• CytRx: lead

Study Sites (2)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UT M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

bafetinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Levitt, M.D., Ph.D.

  CytRx

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

US (2)