Study Stopped
Inadequate accrual rate
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma
3 other identifiers
interventional
72
1 country
7
Brief Summary
This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether it is safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2014
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 20, 2015
April 1, 2015
10 months
April 7, 2014
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.0
Up to 30 days
MTD of ibrutinib defined as the dose level in which no more than 1 out of 6 patients experiences a dose limiting toxicity assessed using NCI CTCAE version 4.0
28 days
Secondary Outcomes (14)
1-year OS
From start of study treatment to death, assessed at 6 months
1-year PFS
From start of study treatment to relapse, progression, or death from any cause, whichever occurs first, assessed at 6 months
6-month overall survival (OS)
From start of study treatment to death, assessed at 6 months
6-month progression free survival (PFS)
From start of study treatment to relapse, progression, or death from any cause, whichever occurs first, assessed at 6 months
Changes in EBV DNA copy numbers in plasma and in PBMCs in relation to ibrutinib therapy
Baseline to up to 30 days
- +9 more secondary outcomes
Study Arms (1)
Treatment (ibrutinib)
EXPERIMENTALPatients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- Known HIV infection and histologically confirmed B-cell non-Hodgkin lymphoma or B-cell lymphoproliferative disease as follows, as defined by the World Health Organization classification:
- Active B-cell non-Hodgkin lymphoma (cluster of differentiation \[CD\]20 positive or negative), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), or multiple myeloma that has relapsed, progressed, or been refractory to at least one regimen
- Note: Patients with CLL, SLL, or mantle cell lymphoma (MCL) may only be enrolled in Stratum C
- At least 14 days between ibrutinib initiation and last cancer therapy; any number of prior cancer therapies is permitted; patients otherwise fit for blood or marrow transplantation (BMT) should receive second-line chemotherapy before considering enrollment
- Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive Western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
- Participants must be on a stable antiretroviral regimen per current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines as follows, with no intention of changing the regimen within 8 weeks after ibrutinib initiation:
- Choice of regimen: The specific antiretroviral agents are at physician discretion, and the use of investigational agents currently available on an expanded-access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) is prohibited
- Patients with mantle cell lymphoma, CLL, or SLL must be on non-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYPA3A4) modulating antiretroviral agents (Stratum C) to be eligible for this study
- Patients may be switched to non-conflicting regimens in order to participate
- Stability of regimen: With the exception of patients on zidovudine-based ART, any changes in antiretroviral regimen must be made at least 4 weeks prior to ibrutinib initiation; patients taking zidovudine-based ART must change to a non-zidovudine-based regimen at least 2 weeks prior to ibrutinib initiation; changes to ART therapy during the study may be made if medically necessary (e.g. toxicity, treatment failure)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky \>= 60%)
- Life expectancy \>= 2 months
- Absolute CD4+ lymphocyte count: \>= 75 cells/uL
- Absolute neutrophil count \>= 750 cells/uL
- Platelets \>= 50,000 cells/uL, or \>= 30,000/uL if bone marrow is involved by malignancy
- +10 more criteria
You may not qualify if:
- Prior exposure to ibrutinib
- Receipt of any investigational agents within 14 days before the first dose of ibrutinib
- Failure to recover to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 2 from clinically significant toxicities due to prior cancer therapies or to any investigational agents
- Active central nervous system involvement by malignancy; central nervous system disease that has been treated into remission is permitted; a chart note of the clinician's impression of lack of central nervous system (CNS) involvement is acceptable
- Patients who require concomitant treatment with CYP3A4/5 strong inhibitors or inducers OTHER than antiretroviral therapies for HIV
- As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter product
- A prednisone equivalent of \< 20 mg daily is permitted in patients requiring chronic use; larger doses must be discontinued \>= 7 days prior to ibrutinib initiation and are prohibited during study treatment
- Anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days prior to starting ibrutinib and throughout the study
- Significant or uncontrolled intercurrent condition including, but not limited to:
- Infection other than HIV, hepatitis B, or hepatitis C that is symptomatic or requires systemic treatment
- Opportunistic infection within 60 days prior to enrollment
- Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infection within 6 months prior to enrollment
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- History of class B or class C cirrhosis, per the modified Child-Pugh classification
- Psychiatric illness that would limit compliance
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
UCLA Center for Clinical AIDS Research and Education
Los Angeles, California, 90035, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvette Kasamon
AIDS Malignancy Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 9, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 20, 2015
Record last verified: 2015-04