Adult B Acute Lymphoblastic LeukemiaPhase 1NCT02109224

Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection

A Phase 1 study testing Ibrutinib, Laboratory Biomarker Analysis and Pharmacological Study in people with Adult B Acute Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 7 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult B Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Cutaneous B-Cell Non-Hodgkin Lymphoma
What is being tested?: Ibrutinib, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 7 sitesUnited States
Study dates: Sep 2014to Jul 2015
Phase: 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

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:

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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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x institutional upper limit of normal (ULN), or =< 5.0 x ULN if attributable to malignancy
Total bilirubin =< 2.0 x ULN, unless elevated bilirubin is attributable to Gilbert's syndrome or to HIV medications (e.g., indinavir, tenofovir, atazanavir)
Creatinine clearance (CrCl) >= 40 mL/min (modified Cockcroft-Gault)
All subjects must be screened for hepatitis B and C infection; subjects must either have no history of hepatitis B or C, or must meet the following criteria in order to e eligible:
Hepatitis B: Subjects infected with hepatitis B must receive anti-hepatitis B therapy; per Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) guidelines, subjects that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen positive [HBsAg+], hepatitis B core antibody positive [HB core AB +], hepatitis B surface antibody negative [HBsAB-]) must be on anti-hepatitis B therapy throughout the study in order to be eligible; the exact hepatitis B therapy is at the discretion of the infection disease specialist or investigator; all patients diagnosed with hepatitis B must also meet the liver function test criteria listed above and have no evidence of cirrhosis; however, all patients who present with acute hepatitis B, or who show normal transaminases but are HBsAg+ and immunoglobulin M positive (IgM+) for hepatitis B core antigen, are ineligible
Hepatitis C: Subjects, who are hepatitis C antibody positive, with or without a positive hepatitis C ribonucleic acid (RNA) level, must meet the liver function test criteria listed above and have no evidence of cirrhosis; patients diagnosed with hepatitis C less than 6 months before enrollment will be considered to have acute hepatitis C and will be ineligible unless the hepatitis C viral load is undetectable
Must in the opinion of the investigator be capable of complying with this protocol
Patients may not begin protocol therapy within 7 days of major surgery or within 3 days of minor surgery
Willingness of sexually active subjects to use adequate contraception; both men and women of child-bearing potential treated or enrolled on this study must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 4 months after completion of ibrutinib; men who only have sex with other men do not need to use contraception specifically for this study; (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)
Ability to understand and willingness to sign a written informed consent document

Who cannot join

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

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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
Inability to swallow capsules whole, or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption, such as malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease affecting the small intestine
History of prior malignancy, with the exception of the following:
Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician
Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
Adequately treated cervical carcinoma in situ without current evidence of disease
Skin-limited Kaposi sarcoma that has not required systemic treatment within 6 months prior to study enrollment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib
Pregnancy or breastfeeding; a pregnancy test must be performed within 7 days prior to ibrutinib initiation in women of childbearing potential; pregnant women are excluded; breastfeeding must be discontinued

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
UCLA Center for Clinical AIDS Research and Education
Los Angeles, California, 90035
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110
Albert Einstein College of Medicine
The Bronx, New York, 10461
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490

Other trials in United States

About this study

Official title: Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma

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.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the safety and tolerability of single-agent ibrutinib in combination with antiretroviral therapy (ART) specifically with respect to ibrutinib metabolism in HIV-infected patients with relapsed or refractory B-cell neoplasms.

II. To determine the maximum tolerated dose (MTD) of ibrutinib in this setting.

SECONDARY OBJECTIVES:

To characterize ibrutinib pharmacokinetics in relation to ART-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) interactions.

II. To describe toxicity in relation to plasma concentrations of ibrutinib and its main metabolite.

III. To estimate objective response rate, clinical benefit, times to tumor response and progression, and 6-month and 1-year progression-free and overall survival.

IV. To describe changes in HIV viral load, immunologic parameters, and Epstein-Barr virus (EBV) and human herpesvirus 8 (HHV-8) deoxyribonucleic acid (DNA) copy numbers in plasma and in peripheral blood mononuclear cells (PBMC) in relation to ibrutinib therapy.

OUTLINE: This is a dose-escalation study.

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Conditions: Adult B Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Cutaneous B-Cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, HIV Infection, Intraocular Lymphoma
Being tested: Ibrutinib, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings: Burkitt Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, HIV Infections, Intraocular Lymphoma, Multi-centric Castleman's Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

IbrutinibDrug
Also called BTK Inhibitor PCI-32765, CRA-032765, PCI-32765
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Pharmacological StudyOther
Correlative studies

Study groups in NCT02109224
Study group	Role	What they receive
Treatment (ibrutinib)	Experimental	Patients 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. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

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

Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.0
Measured: 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
Measured: 28 days

Secondary outcomes (14)

1-year OS
Probabilities of 1-year OS will be estimated with the Kaplan-Meier method and reported with 95% CI.
Measured: From start of study treatment to death, assessed at 6 months
1-year PFS
Probabilities of 1-year PFS will be estimated with the Kaplan-Meier method and reported with 95% CI.
Measured: 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)
Probabilities of 6-month OS will be estimated with the Kaplan-Meier method and reported with 95% CI.
Measured: From start of study treatment to death, assessed at 6 months
6-month progression free survival (PFS)
Probabilities of 6-month PFS will be estimated with the Kaplan-Meier method and reported with 95% CI.
Measured: 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
Changes will be analyzed with descriptive statistics. Where there are sufficient data, repeated measures analysis of variance will be used to assess the effect of ibrutinib on these parameters across time. If the data do not meet the assumptions of normality, the data will either be transformed or Friedman's test (i.e. non-parametric analogue to a repeated measures analysis of variance) will be used.
Measured: Baseline to up to 30 days
Changes in HHV-8 DNA copy numbers in plasma and in PBMCs in relation to ibrutinib therapy
Changes will be analyzed with descriptive statistics. Where there are sufficient data, repeated measures analysis of variance will be used to assess the effect of ibrutinib on these parameters across time. If the data do not meet the assumptions of normality, the data will either be transformed or Friedman's test (i.e. non-parametric analogue to a repeated measures analysis of variance) will be used.
Measured: Baseline to up to 30 days
Changes in HIV viral load
Changes will be analyzed with descriptive statistics. Where there are sufficient data, repeated measures analysis of variance will be used to assess the effect of ibrutinib on these parameters across time. If the data do not meet the assumptions of normality, the data will either be transformed or Friedman's test (i.e. non-parametric analogue to a repeated measures analysis of variance) will be used.
Measured: Baseline to up to 30 days
Changes in immunologic parameters
Changes will be analyzed with descriptive statistics. Where there are sufficient data, repeated measures analysis of variance will be used to assess the effect of ibrutinib on these parameters across time. If the data do not meet the assumptions of normality, the data will either be transformed or Friedman's test (i.e. non-parametric analogue to a repeated measures analysis of variance) will be used.
Measured: Baseline to up to 30 days
Clinical benefit
The proportion of patients achieving clinical benefit and their corresponding 95% CIs will be reported.
Measured: Up to 30 days
Objective response rate
The proportion of patients achieving objective responses and their corresponding 95% confidence intervals (CIs) will be reported.
Measured: Up to 30 days
Pharmacokinetic (PK) parameters of ibrutinib in relation to ART-CYP3A4 interactions, including half-life (T1/2), oral clearance (CL/F), and area under the curve (AUC)
Relevant individual PK parameters will be estimated using non-compartmental or compartmental PK methods. For each stratum, the PK variables will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated for each dose level. Pharmacokinetic parameters (i.e., T1/2, CL/F, and AUC) will be compared across relevant antiretroviral therapies using non-parametric statistical testing techniques.
Measured: Course 1, day 8: pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours
Plasma concentrations of ibrutinib and its main metabolite
Correlations with toxicity will be explored using non-parametric statistical testing techniques.
Measured: Up to 30 days
Time to tumor progression
Time to tumor progression will be reported descriptively with medians and ranges.
Measured: Up to 30 days
Time to tumor response
Time to tumor response will be reported descriptively with medians and ranges.
Measured: From the first study treatment until documentation of first objective response, assessed up to 30 days

Timeline

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

Sep 2014Jul 2015

First posted9 Apr 2014 (estimated)
Study startSep 2014
Primary completionJul 2015
Study completionJul 2015

Why it stopped: Inadequate accrual rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adult B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02109224
Sponsor's protocol ID: NCI-2014-00707
Other IDs: NCI-2014-00707, AMC-091, AMC-091, U01CA121947
Status last verified: Apr 2015
First submitted: 7 Apr 2014
Last updated: 20 Aug 2015
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma
ClinicalTrials.gov ID: NCT02109224
Acronym / sponsor ID: NCI-2014-00707
Conditions: Adult B Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Cutaneous B-Cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, HIV Infection, Intraocular Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inadequate accrual rate
Enrolment: 72 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Sep 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 9 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To evaluate the safety and tolerability of single-agent ibrutinib in combination with antiretroviral therapy (ART) specifically with respect to ibrutinib metabolism in HIV-infected patients with relapsed or refractory B-cell neoplasms.

II. To determine the maximum tolerated dose (MTD) of ibrutinib in this setting.

SECONDARY OBJECTIVES:

To characterize ibrutinib pharmacokinetics in relation to ART-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) interactions.

II. To describe toxicity in relation to plasma concentrations of ibrutinib and its main metabolite.

III. To estimate objective response rate, clinical benefit, times to tumor response and progression, and 6-month and 1-year progression-free and overall survival.

OUTLINE: This is a dose-escalation study.

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (ibrutinib)	Experimental	Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

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:
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:
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky >= 60%)

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IbrutinibAlso: BTK Inhibitor PCI-32765, CRA-032765, PCI-32765Given PO	Drug	Treatment (ibrutinib)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (ibrutinib)
Pharmacological StudyCorrelative studies	Other	Treatment (ibrutinib)

Primary outcome

Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.0
Time frame: 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
Time frame: 28 days

14 secondary outcomes

1-year OS
Time frame: From start of study treatment to death, assessed at 6 months
1-year PFS
Time frame: 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)
Time frame: From start of study treatment to death, assessed at 6 months
6-month progression free survival (PFS)
Time frame: 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
Time frame: Baseline to up to 30 days
Changes in HHV-8 DNA copy numbers in plasma and in PBMCs in relation to ibrutinib therapy
Time frame: Baseline to up to 30 days
Changes in HIV viral load
Time frame: Baseline to up to 30 days
Changes in immunologic parameters
Time frame: Baseline to up to 30 days
Clinical benefit
Time frame: Up to 30 days
Objective response rate
Time frame: Up to 30 days
Pharmacokinetic (PK) parameters of ibrutinib in relation to ART-CYP3A4 interactions, including half-life (T1/2), oral clearance (CL/F), and area under the curve (AUC)
Time frame: Course 1, day 8: pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours
Plasma concentrations of ibrutinib and its main metabolite
Time frame: Up to 30 days
Time to tumor progression
Time frame: Up to 30 days
Time to tumor response
Time frame: From the first study treatment until documentation of first objective response, assessed up to 30 days

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yvette Kasamon principal investigator

AIDS Malignancy Consortium

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 25 inclusion and 23 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Inadequate accrual rate). 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?

Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.0 (time frame: Up to 30 days). The study lists 2 primary outcomes in all. 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 NCT02109224.

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 20 Aug 2015.