Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia

NCT01441882 | Completed Phase 2 Results DMC

• 5 other identifiers: IRB00006146NCI-2011-03136HEM 10010-LOHSU-6146BMS CA180-280
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well dasatinib works in treating patients with chronic lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity

  Defined by a decrease in absolute lymphocyte count, as determined by peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50 % and/or a decrease of detectable total lymph node size or spleen size by 50% (either by clinical examination contrast enhanced computed tomography \[CT\]).

  8 weeks

Secondary Outcomes (4)

• Objective Response

  Up to 2 years

• Overall Survival

  Up to 2 years

• Progression-free Survival

  Up to 2 years

• Incidence of Adverse Events (Number of Participants Affected)

  Up to 4 years

Study Arms (1)

Treatment (dasatinib)

EXPERIMENTAL

Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Dasatinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Dasatinib DRUG

Given PO

Also known as: BMS-354825, Sprycel

Treatment (dasatinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (dasatinib)

Pharmacological Study OTHER

Correlative studies

Treatment (dasatinib)

Eligibility Criteria

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

You may qualify if:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal information
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• In vitro dasatinib sensitivity (IC 50 =\< 50 nm per MTS assay)
• Diagnosis of CLL and must meet one of the following:
• Relapsed CLL in all patients who have failed at least one prior treatment, regardless of risk group
• OR De novo (treatment-naïve) patients age \>= 65 who are not candidates for or do not want to pursue aggressive chemotherapy treatment
• Have indications for treatment or evidence of progressive disease defined as follows (1996 NCI working group):
• Massive or progressive splenomegaly
• Massive lymph nodes (\>= 10 cm), nodal clusters (\>= 10 cm), or progressive lymphadenopathy
• Symptomatic anemia and/or thrombocytopenia (Rai stages III or IV disease)
• Autoimmune hemolytic anemia and/or thrombocytopenia that are poorly responsive to corticosteroid therapy
• Progressive lymphocytosis with increase in lymphocyte count of \>= 50% over a 2-month period or an anticipated doubling time of \< 6 months
• Repeated episodes of infection
• Have not received CLL treatment within the past 2 weeks
• Total bilirubin \< 2.0 x upper limit of normal (ULN)

You may not qualify if:

• Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy
• Pleural or pericardial effusion of any grade
• Uncontrolled angina, \> New York Heart Association (NYHA) class III congestive heart failure or myocardial infarction (MI) within 6 months prior to study enrollment
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
• Subjects who are detained or imprisoned are not eligible
• History of significant bleeding disorder unrelated to cancer, including:
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• May not take concomitant medications that are generally accepted to have a risk of causing Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib)
• Quinidine, procainamide, disopyramide
• Amiodarone, sotalol, ibutilide, dofetilide
• Erythromycin, clarithromycin
• Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; 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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

No limitations or caveats are noted at this time.

Results Point of Contact

• Title: Stephen Spurgeon
• Organization: Oregon Health & Science University

spurgeos@ohsu.edu

503-494-4606

Study Officials

• Stephen Spurgeon

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2011
• Primary Completion: July 12, 2016
• Study Completion: January 1, 2018
• Last Updated: April 8, 2021
• Results First Posted: February 15, 2018

Record last verified: 2021-03

Locations

US (1)