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Trial record 7 of 307 for:    IBRUTINIB

A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02801578
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Ibrutinib is currently FDA approved and commercially available for the treatment of CLL. However, some researchers think the approved dose may be unnecessarily high.

The goal of this clinical research study is to compare 3 different daily doses of ibrutinib to learn how these doses affect the disease and your body. Researchers think that if a lower dose of ibrutinib can be found to be as effective as the currently approved dose this may help to lower the risk of side effects.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Ibrutinib Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : July 6, 2016
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019


Arm Intervention/treatment
Experimental: Ibrutinib

Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.

During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.

Drug: Ibrutinib
Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
Other Names:
  • PCI-32765
  • Imbruvica




Primary Outcome Measures :
  1. Change in Bruton's Tyrosine Kinase (BTK) Occupancy in Different Daily Doses of Ibrutinib in Participants with Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Just before dosing and at 4 and 24 hours post-dosing on Days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle ]

    Participants receive three 28 day cycles with decreasing dose levels.

    BTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of CLL (any stage) with ALC >/= 20 x 109/l, requiring therapy.
  2. Able to receive ibrutinib through commercial supply, i.e., insured patients meeting FDA-approved indications.
  3. Age >/=18 years.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. Adequate end organ function, defined as the following: total bilirubin </= 1.5 x upper limit of normal (ULN, unless due to Gilbert syndrome, in which case it should be </= 3.0 x ULN), ALT and AST </= 2.5 x ULN, CrCL >/= 25 ml/min.
  6. Able to understand and sign the IRB-approved informed consent document for this trial.
  7. Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study. Male patients who are partners of WOCBP should also practice an effective method of contraception. Effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization. Postmenopausal women must be amenorrheic for >/= 12 months to be considered of non-childbearing potential, Women and men must continue birth control for the duration of the trial and >/= 3 months after the last dose of study drug, All WOCBP MUST have a negative pregnancy test prior to beginning ibrutinib on study.
  8. Patients should have discontinued any and all other therapy for CLL >/= 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade </= 1.

Exclusion Criteria:

  1. Previous treatment with ibrutinib.
  2. Current therapy with warfarin or other anticoagulants at therapeutic doses, e.g., low molecular weight heparin, fondaparinux, dabigatran, rivaroxaban, apixaban or edoxaban that are unable to be discontinued.
  3. Active gastrointestinal conditions that are expected to impair absorption of orally administered medications.
  4. Active, uncontrolled infection.
  5. History of hypersensitivity to ibrutinib.
  6. Pregnancy or lactation.
  7. Patients with leukemic involvement of the central nervous system.
  8. Patients who currently have or have a history of the following within 6 months preceding study entry are not eligible: Unstable angina (UA) or myocardial infarction (MI), Clinically significant atrial or ventricular arrhythmias (e.g., AF, atrial flutter, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), New York Heart Association (NYHA) class III or IV heart failure.
  9. Patients on strong CYP3A inducers or inhibitors that are unable to be discontinued. The list of drugs that interact with cytochrome P450 enzymes can be found online at: http://medicine.iupui.edu/clinpharm/DDIs/ClinicalTable.aspx

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): NCT02801578


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Prithviraj Bose, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02801578     History of Changes
Other Study ID Numbers: 2016-0226
NCI-2016-01091 ( Registry Identifier: NCI CTRP )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Malignant neoplasms stated as primary lymphoid haematopoietic
Ibrutinib
PCI-32765
Imbruvica
Pharmacodynamics

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell