NCT02801578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

July 6, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 27, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

May 27, 2016

Results QC Date

February 7, 2020

Last Update Submit

February 25, 2020

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaCLLMalignant neoplasms stated as primary lymphoid haematopoieticIbrutinibPCI-32765ImbruvicaPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy

    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.

    3 cycles, up to 90 days

Study Arms (1)

Ibrutinib

EXPERIMENTAL

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

Interventions

IbrutinibDRUG

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).

Also known as: PCI-32765, Imbruvica
Ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of CLL (any stage) with ALC \>/= 20 x 109/l, requiring therapy.
  • Able to receive ibrutinib through commercial supply, i.e., insured patients meeting FDA-approved indications.
  • Age \>/=18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • 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.
  • Able to understand and sign the IRB-approved informed consent document for this trial.
  • 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.
  • 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.

You may not qualify if:

  • Previous treatment with ibrutinib.
  • 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.
  • Active gastrointestinal conditions that are expected to impair absorption of orally administered medications.
  • Active, uncontrolled infection.
  • History of hypersensitivity to ibrutinib.
  • Pregnancy or lactation.
  • Patients with leukemic involvement of the central nervous system.
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chen LS, Bose P, Cruz ND, Jiang Y, Wu Q, Thompson PA, Feng S, Kroll MH, Qiao W, Huang X, Jain N, Wierda WG, Keating MJ, Gandhi V. A pilot study of lower doses of ibrutinib in patients with chronic lymphocytic leukemia. Blood. 2018 Nov 22;132(21):2249-2259. doi: 10.1182/blood-2018-06-860593. Epub 2018 Sep 25.

    PMID: 30254130DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prithviraj Bose, MD./Associate Professor
Organization
The University of Texas MD Anderson Cancer Center
PBose@mdanderson.org
713-792-7747

Study Officials

  • Prithviraj Bose, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
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
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 16, 2016

Study Start

July 6, 2016

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

February 27, 2020

Results First Posted

February 27, 2020

Record last verified: 2020-02

Locations

US(1)