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Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by University of Washington
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT02207062
First received: July 30, 2014
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
This pilot clinical trial studies ibrutinib in treating patients with transformed indolent (a type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a period of improvement or do not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes (proteins) needed for cell growth.

Condition Intervention
Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Indolent Adult Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Drug: Ibrutinib Other: Laboratory Biomarker Analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot Study of Single-Agent Ibrutinib in Relapsed or Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Overall response rate (combined complete response + partial response) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • Complete response rate [ Time Frame: Up to 5 years ]
  • Disease control rate [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: Time from first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years ]
    Progression-free survival will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).

  • Response rate relative to the underlying B-cell histology [ Time Frame: Up to 5 years ]
  • Tolerability of chronic ibrutinib therapy [ Time Frame: Up to 5 years ]
    The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to classify and grade toxicities.


Estimated Enrollment: 20
Study Start Date: October 2014
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity.
Drug: Ibrutinib
Given PO
Other Names:
  • BTK Inhibitor PCI-32765
  • CRA-032765
  • PCI-32765
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Perform a preliminary assessment of the efficacy of single-agent ibrutinib, based on overall response rate, in subjects with relapsed or refractory transformed indolent B-cell non-Hodgkin lymphoma (R/R TIL).

SECONDARY OBJECTIVES:

I. To determine the tolerability of chronic ibrutinib therapy in this patient population.

II. To determine the disease control rate of this regimen.

III. Evaluate the complete response rate, overall survival, and progression-free survival to single-agent ibrutinib in this patient population.

IV. Determine response rate relative to the underlying B-cell histology.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed transformed indolent B-cell non-Hodgkin lymphoma that is relapsed or refractory to at least one line of therapy
  • Patients must have a computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis within 28 days of enrollment
  • Patients must have measurable disease defined as lesions greater than 1.5 cm that can be accurately measured in two dimensions by CT (preferred), or MRI
  • Patients must have a positron emission tomography (PET) scan within 56 days of enrollment
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Absolute neutrophil count (ANC) >= 1000/mm^3 or >= 750/mm^3 in the setting of marrow involvement by disease
  • Platelets >= 50,000/mm^3 or >= 30,000/mm^3 in the setting of marrow involvement by disease or splenomegaly due to disease
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Creatinine clearance (Clcr) > 25 mL/min
  • Patients must be anticipated to complete 2 cycles of therapy in the opinion of the treating physician
  • Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
  • Sign (or their legally-acceptable representatives must sign) an informed consent document in accordance with institutional and federal guidelines indicating that they understand the investigational nature of and procedures required for the study, including biomarkers, and are willing to participate in and comply with the guidelines of the study

Exclusion Criteria:

  • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection
  • Major surgery or a wound that has not fully healed within 4 weeks of initiation of therapy
  • Known central nervous system lymphoma
  • History of stroke or intracranial hemorrhage within 6 months of screening
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
  • Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Vaccinated with live, attenuated vaccines within 4 weeks of initiation of therapy
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol sponsor-investigator/lead-sub-investigator
  • Patients that previously were treated with ibrutinib for > 7 days
  • Previous chemotherapy, immunotherapy, biologically targeted therapy, other investigational agent, or radiation therapy within 3 weeks of initiation of ibrutinib therapy or radio-immunotherapy within 12 weeks of initiation of ibrutinib therapy
  • Prior allogeneic transplant with graft-versus-host disease (GVHD) requiring immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207062

Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Ajay K. Gopal    206-288-2037    agopal@u.washington.edu   
Principal Investigator: Ajay K. Gopal         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ajay Gopal Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02207062     History of Changes
Other Study ID Numbers: 9107
NCI-2014-01573 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9107 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: July 30, 2014
Last Updated: March 7, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 28, 2017