Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma

NCT01849263 | Active Not Recruiting Phase 2 Results

• 7 other identifiers: NCI-2013-00887MC12829271N01CM00032N01CM00099P30CA015083U10CA180821
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 13

Brief Summary

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.

Conditions

Grade 3a Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Refractory Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate defined as a partial response (PR) or complete response (CR) as the objective status at any time during treatment, evaluated using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated. A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen.

  Up to 5 years

Secondary Outcomes (6)

• Duration of Response

  Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years

• Overall Survival

  Assessed up to 5 years

• Progression-free Survival

  Time from registration to progression or death due to any cause, assessed up to 5 years

• Time to Response

  Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR, assessed up to 5 years

• Time to Subsequent Treatment

  Time from registration to the date of initiation of subsequent treatment for lymphoma, assessed up to 5 years

Study Arms (1)

Treatment (ibrutinib)

EXPERIMENTAL

Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.

Drug: Ibrutinib; Other: Laboratory Biomarker Analysis

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765

Treatment (ibrutinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ibrutinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Active central nervous system (CNS) involvement
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (13)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

National University Hospital Singapore

Singapore, 119074, Singapore

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Related Publications (1)

• Bartlett NL, Costello BA, LaPlant BR, Ansell SM, Kuruvilla JG, Reeder CB, Thye LS, Anderson DM, Krysiak K, Ramirez C, Qi J, Siegel BA, Griffith M, Griffith OL, Gomez F, Fehniger TA. Single-agent ibrutinib in relapsed or refractory follicular lymphoma: a phase 2 consortium trial. Blood. 2018 Jan 11;131(2):182-190. doi: 10.1182/blood-2017-09-804641. Epub 2017 Oct 26.

  PMID: 29074501 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Nancy L. Bartlett, M.D.
• Organization: Washington University School of Medicine

nbartlet@dom.wustl.edu

Study Officials

• Nancy L Bartlett

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: April 2, 2013
• Primary Completion: June 3, 2016
• Study Completion (Estimated): March 19, 2027
• Last Updated: April 30, 2026
• Results First Posted: April 26, 2018

Record last verified: 2026-03

Locations

CA (3); SG (2); US (8)