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Follicular LymphomaEarly Phase 1NCT02966730

Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy

A Early Phase 1 study testing Ibrutinib in people with Follicular Lymphoma and Follicular Lymphoma, Grade 1, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to find out how successful ibrutinib is at putting follicular lymphoma into full remission. In this study, remission will be determined by achieving a normal PET scan after treatment. A PET scan is an imaging test that looks for active lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
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
2 participants
Where
9 sitesUnited States
Study dates
Nov 2016to 20 Jun 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • Follicular lymphoma with histology documented by the participating institution (grades 1, 2 or 3a).
  • °For subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase (LDH), rapidly worsening disease, or frequent B-symptoms, a pre-treatment biopsy is required to rule out large cell transformation
  • Completion of a full course of first line immunochemotherapy including rituximab OR completion of 4 cycles of first line immunochemotherapy including rituximab if intolerant (e.g. which include, but are not limited to, R-CHOP, R-CVP, Bendamustine-R).
  • Patients must have achieved PR to primary treatment and not be refractory to prior treatment.
  • Residual FDG-PET activity defined as Deauville 4 or 5 on a PET-CT within 3 and 8 weeks post the last dose of front line therapy.
  • Treatment must begin within 90 days of the last dose of immunochemotherapy.
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  • Men and women ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • ≥ 1 measurable disease site on computed tomography (CT) scan or positron emission tomography (PET) (1.5 cm in longest dimension). (In select cases, for example extremity lesions, an MRI may be substituted.)
  • Life expectancy of > 3 months, in the opinion of the investigator.
  • Female subjects who are of non-reproductive potential (i.e. post-menopausal by history - no menses for ≥ 2 years; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.
  • Male and female subjects who agree to use highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g. condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days (females) and 90 days (males) after the last dose of study drug.

Who cannot join

  • Medically apparent central nervous system lymphoma or leptomeningeal disease.
  • History of any other active malignancies.
  • History of any prior cancer curatively treated within the last two years except:
  • Any non-melanoma skin cancer
  • Any cancer excised, not treated with chemotherapy and with less than a 30% chance of recurrence within the next 2 years from registration
  • History of any organ transplantation.
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  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • More than one prior line of any systemic chemoimmunotherapy for follicular lymphoma.
  • Chemotherapy ≤ 21 days prior to first administration of study treatment and/or monoclonal antibody ≥ 3 weeks prior to first administration of study treatment.
  • Prior exposure to radio- or toxin-immunoconjugates.
  • Concurrent use of warfarin or other vitamin K antagonists.
  • Concurrent use of a strong cytochrome P450 (CYP)3A4/5 inhibitor.
  • Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of > 20 mg/day of prednisone) within 28 days of the first dose of study drug.
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
  • Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, or corrected QT interval (QTc) >/= 470 msec.
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (new York Heart Association >Class 2), unstable angina, uncontrolled hypertension, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
  • Any uncontrolled active systemic infection or recent infection requiring intravenous anti-infective treatment that was complete ≤ 14 days before the first dose of study drug.
  • Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.0), Grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia.
  • Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia.
  • Known history of infection with human immunodeficiency virus (HIV) or history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), or any uncontrolled active systemic infection. Hepatitis B surface antigen must be confirmed negative within on year before enrollment. Subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
  • Any of the following abnormalities
  • Absolute neutrophil count (ANC) <750 cells/mm^3 (0.75 x 10^9/L)
  • Platelet count <50,000 cells/mm^3 (50 x 10^9/L) independent of transfusion support
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≥3.0 x upper limit of normal (ULN)
  • Creatinine clearance (CrCl) <30mL/min
  • Hemoglobin <8.0 g/dL
  • Bilirubin >1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
  • PT/INR >1.5 x ULN and PTT (aPTT) >1.5 x ULN(unless abnormalities are unrelated to coagulopathy or bleeding disorder).
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.
  • Major surgery planned within 4 weeks of the first dose of study drug.
  • Any life-threatening illness, medical condition, including uncontrolled diabetes mellitus (DM), or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
  • Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib.
  • Lactating or pregnant.
  • Unwilling or unable to participate in all required study evaluations and procedures.
  • Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
  • Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Memorial Sloan Kettering Cancer Center @ Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan - Kettering Cancer Center

    New York, New York, 10021

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

Other trials in United States

About this study

Official title: Protocol 20060 (PCYC): A Multicenter, Open-Label Pilot Study of Follicular Lymphoma Ibrutinib Consolidation for FDG-PET Positivity After Frontline Chemoimmunotherapy (FLIPP)

The purpose of this study is to find out how successful ibrutinib is at putting follicular lymphoma into full remission. In this study, remission will be determined by achieving a normal PET scan after treatment. A PET scan is an imaging test that looks for active lymphoma. People who don't have a complete remission on PET after their first treatment are at high risk for having their lymphoma return. This study will investigate if ibrutinib will help participants achieve a complete remission without giving additional chemotherapy. The study will also investigate any possible side effects of the study drug ibrutinib.

Being tested
Ibrutinib
Keywords
follicular lymphoma, Ibrutinib, FLIPP, 16-396
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • IbrutinibDrug

    Ibrutinib will be administered orally, on a once daily continuous dosing schedule and in an outpatient setting. Treatment will continue for 2 years and there will be no planned treatment breaks. The dose of Ibrutinib will be initiated at 560mg per day, which will remain constant throughout the study period, unless otherwise specified.

Study groups in NCT02966730
Study groupRoleWhat they receive
Follicular LymphomaExperimentalParticipants will be receive Ibrutinib as an oral capsule preparation once daily for a period of 2 years. The dose will be 560mg daily. Toxicities will be recorded and graded. Response to treatment will be determined by FDG-PET imaging every 6 months, or as clinically indicated, in conjunction with clinical assessment by a physician, including physical examination, every 4 weeks from day 1 (baseline) for the first 3 months and then every 3 months until the end of treatment at 2 years.
Receives: Drug: Ibrutinib

What is being measured

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

  1. Rate of conversion from FDG-PET positive to negative

    The primary objective is to determine the rate of conversion from FDG-PET positive to negative at 12 months from the start of ibrutinib in patients receiving at least 6 months of Ibrutinib consolidation therapy for follicular lymphoma achieving at least a PR but remaining FDG-PET positive after first line chemoimmunotherapy.

    Measured: 12 months

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion20 Jun 2019
  4. Study completion20 Jun 2019

Why it stopped: Lack of accrual

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966730
Sponsor's protocol ID
16-396
Status last verified
Jun 2019
First submitted
14 Nov 2016
Last updated
13 May 2025
Results posted
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ibrutinib in people with Follicular Lymphoma and Follicular Lymphoma, Grade 1, run by Memorial Sloan Kettering Cancer Center at 9 sites 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 12 inclusion and 36 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: stopped early, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.

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?

Rate of conversion from FDG-PET positive to negative (time frame: 12 months). 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 NCT02966730.

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 13 May 2025.

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