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

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ClinicalTrials.gov Identifier: NCT02815059
Recruitment Status : Withdrawn (Termination of Investigator Initiated Studies using Ibrutinib)
First Posted : June 28, 2016
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Ibrutinib Drug: Dasatinib Drug: Prednisone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018


Arm Intervention/treatment
Experimental: Ibrutinib, Dasatinib and prednisone, all patients Drug: Ibrutinib
Ibrutinib 420mg PO daily (dose level 0) or 560mg PO daily (dose level +1) administered Day 15 through day 90.

Drug: Dasatinib
Dasatinib 100mg PO daily (Day 1 through Day 90). Dasatinib dose will be increased to 140mg daily in patients tolerating dasatinib 100mg who have not achieved a complete bone marrow response (less than 5% blasts) by Day 22 or who have not achieved major molecular response by Day 43.

Drug: Prednisone
Prednisone 60mg/m2 PO daily (Day 1 through Day 32)




Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815059


Locations
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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Janssen, LP

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02815059     History of Changes
Other Study ID Numbers: HCI85188
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Prednisone
Dasatinib
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action