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NCT01849263Active, not recruitingPhase 2

Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma

Phase 2 Trial of Single-Agent Ibrutinib (PCI-32765) in Relapsed or Refractory Follicular Lymphoma

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

This phase II trial studies how well ibrutinib works in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
41 (actual)
First submitted
6 May 2013
Start date
2 Apr 2013
Primary completion date
3 Jun 2016
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT01849263

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 41
  • From 2 Apr 2013 to the primary completion date, 3 Jun 2016
  • 13 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any of the following:
    • Chemotherapy/systemic therapy =\< 4 weeks prior to registration
    • Radiotherapy =\< 4 weeks prior to registration
    • Nitrosoureas or mitomycin C =\< 6 weeks prior to registration
    • Those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
    • Major surgery =\< 10 days prior to registration or minor surgery =\< 7 days prior to registration
    • Prior therapy with ibrutinib or another Bruton's tyrosine kinase inhibitor
    • Receiving any other investigational agents
  • Receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3 subfamily A member 4/5 (CYP3A4/5)
  • Any of the following:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
    • Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ibrutinib administration
    • Note: Breastfeeding should be discontinued if the mother is treated with ibrutinib
  • Known histological transformation from follicular lymphoma to diffuse large B-cell lymphoma
    • Note: A prior history of adequately treated transformed lymphoma does not exclude a patient if the current active disease is biopsy-proven follicular lymphoma
  • History of stroke or intracranial hemorrhage =\< 6 months prior to the first dose of study drug
  • Requires anticoagulation with warfarin or similar vitamin K antagonist
    • Note: Warfarin or similar vitamin K antagonist must have been discontinued at least 28 days prior to study entry
  • Concurrent treatment with therapeutic doses (\> 20 mg prednisone or equivalent) of systemic steroids within 14 days of start of protocol therapy
  • Prior history of allogeneic stem cell transplant

Other illness

  • Known active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection,
    • Uncontrolled diabetes mellitus
    • Cardiac disease
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • "Currently active" second malignancy, other than non-melanoma skin cancers
    • Note: Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib

Lab values

  • Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
    • Note: HIV-positive patients who are not on anti-viral medications that are strong CYP3A4/5 inhibitors and who do not have cluster of differentiation (CD)4 counts less than the lower limit of normal by institutional criteria are eligible; no patients with CD4 counts below institutional normals are eligible

Other

  • Active central nervous system (CNS) involvement
  • Patient has the inability to swallow tablets

Who the study is looking for

  • Histologically confirmed diagnosis of follicular lymphoma, grade 1, 2, or 3a
    • Note: Fresh (frozen) tumor biopsy must be available or attempted; a frozen tumor biopsy equivalent to a minimum of four at least 16 gauge needle cores is an important component of this study; patients without adequate frozen material should have a biopsy performed to obtain material; if biopsy is performed and does not yield adequate material, the patient is still eligible for the study; if a biopsy cannot be done safely, the patient may still be eligible for the study if permission is granted in writing (email) by the study chair (Dr. Nancy Bartlett) or her designees; Dr. Bartlett may be consulted to discuss situations involving invasive biopsy procedures that may pose an increased risk to the patient
  • Measurable disease as defined by a lymph node or tumor mass that is \>= 1.5 cm in at least one dimension by CT or the CT portion of the PET/CT
  • Relapsed or refractory follicular lymphoma which has progressed during or following 1 or more prior chemotherapy regimens for lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Absolute neutrophil count \>= 750/mm\^3 (0.75 x 10\^9/L)
  • Hemoglobin \>= 8.0 g/dL
  • Platelets \>= 30,000/mm\^3 (30 x 10\^9/L)
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) unless Gilbert's syndrome or disease infiltration of the liver is present
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.0 x institutional ULN
  • Creatinine =\< 2.0 x institutional ULN
  • Creatinine clearance (estimated \[est.\] glomerular filtration rate \[GFR\] Cockcroft-Gault) \>= 30 mL/min
  • Negative serum pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to provide biologic samples for correlative research purposes

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Juravinski Cancer Centre at Hamilton Health Sciences
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Kingston Health Sciences Centre
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KingstonCanadaUnknown status
University Health Network, Princess Margaret Hospital
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
National Cancer Centre Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
National University Hospital Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Mayo Clinic in Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
Coordinator of this site? Confirm its status
Saint Louis ParkUnited StatesUnknown status
Metro-Minnesota Community Oncology Research Consortium
Coordinator of this site? Confirm its status
Saint Louis ParkUnited StatesUnknown status
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.