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Chronic Lymphocytic LeukemiaPhase 2/3NCT02801578

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

A Phase 2/3 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
6 Jul 2016to 28 Jan 2019
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

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.

Read the detailed description

Study Drug Administration:

Each study cycle is 28 days.

If you are found to be eligible to take part in this study, you will take ibrutinib capsules by mouth every day for 3 cycles. Each dose of ibrutinib should be taken at about the same time, either with or without food.

During Cycle 1, you will receive the highest dose of ibrutinib (the dose that is currently FDA approved). You will take 3 capsules each day during Cycle 1. During Cycle 2, you will receive the second-highest dose and you will take 2 capsules each day. During Cycle 3, you will take the lowest dose of ibrutinib and you will take 1 capsule each day.

You must swallow the ibrutinib capsules whole without opening, breaking, or chewing them.

You will be given a study drug diary to keep track of each dose of ibrutinib taken, including the time the dose was taken, any missed or vomited doses and the reason for missing the dose, and any doses that you vomited.

Study Visits:

On Days 1, 8 and 28 of each cycle blood (about 1-2 tablespoons total) will be drawn before your dose of ibrutinib and then at 4 and 24 hours after your dose for pharmacodynamic (PD) and pharmacokinetic (PK) testing, to help researchers understand how ibrutinib works in the body, and to learn if the dose you are taking is as effective as other doses (Exception: there will be no 4-hour blood draw on day 28). PK testing measures the amount of study drug in the body at different time points. PD testing measures how the level of study drug in your body may affect the disease. You will need to return to the clinic on the following day (Days 2, 9 and 29 of each cycle [Day 1 of the next cycle]) for the last blood draw.

On Day 28 of each cycle:

  • You will have a physical exam
  • Blood (about 1-2 tablespoons) will be drawn for routine tests.
  • You will have an EKG.

Length of Study:

You may receive ibrutinib on this study for up to 3 cycles. After this time, you will continue treatment for CLL as directed by your doctor. This may or may not include ibrutinib. If you do continue to take ibrutinib after the study is over, your doctor will determine the best dose for you to be taking.

You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after your last dose of ibrutinib (after the end of Cycle 3).

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of CLL. It is considered investigational to compare 3 different doses of ibrutinib. The study doctor can explain how the study drug is designed to work.

Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.

Being tested
Ibrutinib
Keywords
Chronic Lymphocytic Leukemia, CLL, Malignant neoplasms stated as primary lymphoid haematopoietic, Ibrutinib, PCI-32765, Imbruvica, Pharmacodynamics
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbrutinibDrug

    Also called PCI-32765, Imbruvica

    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).

Study groups in NCT02801578
Study groupRoleWhat they receive
IbrutinibExperimentalParticipants 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.
Receives: Drug: Ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 cycles, up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study start6 Jul 2016
  3. Primary completion28 Jan 2019
  4. Study completion28 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02801578
Sponsor's protocol ID
2016-0226
Other IDs
NCI-2016-01091
Status last verified
Feb 2020
First submitted
27 May 2016
Last updated
27 Feb 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30254130

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy (time frame: 3 cycles, up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02801578, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.

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