Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01144260
Other study ID # BAFETINIB-P2-CLL-01
Secondary ID
Status Completed
Phase Phase 2
First received June 9, 2010
Last updated May 14, 2013
Start date June 2010
Est. completion date April 2013

Study information

Verified date May 2013
Source CytRx
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2013
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States City of Hope National Medical Center Duarte California
United States UT M.D. Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
CytRx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL Upto 6 months or disease progression No
Secondary Adverse Events 1 year Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03204188 - Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Phase 2
Terminated NCT00377104 - Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Phase 1
Completed NCT00006226 - Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Phase 2
Completed NCT01576588 - Rituximab in Pretreated Elderly or Unfit B-CLL Patients Phase 2
Completed NCT01212380 - Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL) Phase 1
Terminated NCT00288067 - Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT00098670 - Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia Phase 2
Completed NCT00910910 - Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) Phase 3
Recruiting NCT03110640 - Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma Phase 1
Terminated NCT00101205 - Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Completed NCT00005799 - Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer N/A
Terminated NCT02440685 - A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01105247 - Safety of PCI-32765 in Chronic Lymphocytic Leukemia Phase 1/Phase 2
Terminated NCT01126502 - Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia Phase 1
Completed NCT00321724 - AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia Phase 2
Completed NCT02381080 - Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy Phase 1
Completed NCT04030195 - Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL Phase 1/Phase 2
Withdrawn NCT00918450 - Study Assessing the Safety and Efficacy of ABT-263 in Subjects With B-cell Chronic Lymphocytic Leukemia (CLL) Who Have Failed at Least One Prior Fludarabine-containing Regimen Phase 2
Terminated NCT00302861 - A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Phase 1/Phase 2
Completed NCT00565981 - A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response Phase 2