Clinical Trials /

Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone

NCT02815059

Description:

This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone therapy.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Withdrawn

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone
  • Official Title: A Phase 1 Study of Combining Ibrutinib, Dasatinib and Prednisone in Patients 60 Years or Older With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: HCI85188
  • NCT ID: NCT02815059

Conditions

  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
IbrutinibIbrutinib, Dasatinib and prednisone, all patients
DasatinibIbrutinib, Dasatinib and prednisone, all patients
PrednisoneIbrutinib, Dasatinib and prednisone, all patients

Purpose

This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone therapy.

Trial Arms

NameTypeDescriptionInterventions
Ibrutinib, Dasatinib and prednisone, all patientsExperimental
  • Ibrutinib
  • Dasatinib
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed new diagnosis of Philadelphia chromosome-positive or BCR-ABL1 positive
             precursor B cell acute lymphoblastic leukemia (B-ALL) based on ≥ 20% lymphoblasts in
             bone marrow or blood. Outside specimens will be subject to central review at the HCI
             (Huntsman Cancer Institute) Department of Pathology. BCR-ABL1 or
             Philadelphia-chromosome positivity may be determined by RT-PCR, conventional
             cytogenetics and/or FISH.

          -  Men and woman ≥ 50 years of age

          -  ECOG status 0 - 2

          -  Biochemical values as defined by the protocol.

          -  Women of childbearing potential and men who are sexually active must be practicing a
             highly effective method of birth control during and after the study consistent with
             local regulations regarding the use of birth control methods for subjects
             participating in clinical trials. Men must agree to not donate sperm during and after
             the study. For women, these restrictions apply for 1 month after the last dose of
             study drug. For men, these restrictions apply for 3 months after the last dose of
             study drug.

          -  Women of childbearing potential must have a negative serum (beta-human chorionic
             gonadotropin [β-hCG]) or urine pregnancy test at screening within 7 days of
             enrollment.

          -  Able to provide informed consent and willing to sign an approved consent form that
             conforms to federal and institutional guidelines.

        Exclusion Criteria:

          -  Major surgery or a wound that has not fully healed within 4 weeks of enrollment.

          -  Prior exposure to dasatinib (>7 days), Bruton's tyrosine kinase inhibitor exposure, or
             prior chemotherapy for ALL (up to 7 days of steroids are allowed)

          -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

          -  Grade ≥ 2 QTc prolongation on screening ECG within 28 days of enrollment, or history
             of ventricular arrhythmia.

          -  Clinically significant cardiovascular disease such as uncontrolled or symptomatic
             arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
             screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by
             the New York Heart Association Functional Classification.

          -  Hepatic impairment (Child Pugh Classes A- C) that is not considered to be the result
             of leukemic involvement as determined by the PI

          -  Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg,
             phenprocoumon).

          -  Requires chronic treatment with strong CYP3A inhibitors.

          -  Vaccinated with live, attenuated vaccines within 4 weeks of enrollment.

          -  Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or
             active Hepatitis B Virus infection or any uncontrolled active systemic infection.

          -  Women who are pregnant or breastfeeding.

          -  Herbal preparations or over-the-counter supplements containing herbal ingredients (St.
             John's Wort, Estroven, Blue Cohosh) are prohibited during treatment and must be
             stopped within 24h of first dose of ibrutinib.

          -  Any life-threatening illness, medical condition, or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue
             risk.

          -  Known central nervous system lymphoma (does not include diagnosis of ALL with CNS
             involvement)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events of combination of ibrutinib and dasatinib
Time Frame:Patient safety will be evaluated throughout the treatment period (treatment with Ibrutinib and dasatinib which is expected to last 90 days for each patient)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:University of Utah

Last Updated

January 31, 2018