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Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

Primary Purpose

AIDS-Related Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Doxorubicin Hydrochloride
Etoposide
Filgrastim
Ibrutinib
Laboratory Biomarker Analysis
Pegfilgrastim
Pharmacological Study
Prednisone
Rituximab
Vincristine Sulfate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS-Related Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive or negative diffuse large B-cell lymphoma (DLBCL)
  • Tissue available from the diagnostic biopsy in the form of blocks, tissue cores, or slides available for submission to central pathology is required for all participants enrolled to this study; formalin-fixed paraffin-embedded tissue from diagnostic tissue is acceptable and recommended; submission of the institutional diagnostic slides is also preferred for all participants enrolled in the study
  • Stage II-IV disease; participant will need measurable disease by computed tomography (CT) or positron emission tomography (PET) scans if enrolled in the dose-expansion cohort
  • HIV positive; documentation of HIV-1 infection by means of any one of the following:

    • Documentation of HIV diagnosis in the medical record by a licensed health care provider;
    • Documentation of receipt of ART (at least three different medications) by a licensed health care provider (documentation may be a record of an antiretroviral therapy (ART) prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name);
    • HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;
    • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay
    • NOTE: a "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay, which is required for all investigational food drug (IND) studies
  • Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
  • CD4 count >= 100 in the dose-finding cohort; once the dose-finding cohort is complete and if safety is established, participants with any CD4 count, including CD4 count < 100, will be allowed in the dose-escalation phase
  • Absolute neutrophil count: >= 1,000/mm^3, unless decreased due to bone marrow involvement with lymphoma
  • Platelets: >= 75,000/mm^3, unless decreased due to bone marrow involvement with lymphoma
  • Total bilirubin: =< 1.5 institutional upper limit of normal (ULN); if potential due to lymphoma, the first cycle may be given without ibrutinib and if transaminitis and bilirubinemia improves to meet parameters, participant mat be enrolled on the clinical trial
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]): < 2 institutional ULN; if potentially due to lymphoma, the first cycle will be given without ibrutinib and if transaminitis and bilirubinemia improves to meet parameters, participant may be enrolled on trial
  • Creatinine levels within normal institutional limits; or, creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal; unless decreased due to renal involvement by lymphoma
  • Participants must not be on medications, including antiretroviral (ARV) regimens such as cobicistat, indinavir, or ritonavir, or agents with moderate or strong CYP3A4 inhibition; if on a moderate or strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to a qualifying regimen with the last dose of the strong CYP3A4 inhibitor taken at least one week before administration of ibrutinib
  • Willingness of sexually active participants 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, 90 days after completion of ibrutinib, and 12 months after the last dose of rituximab, whichever comes last; 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)
  • All participants will be required to be screened for hepatitis B; all participants who present with acute hepatitis B or show normal transaminases and are hepatitis B surface antigen (HBsAg) positive (+) and IgM+ for hepatitis core antigen will not be eligible for trial enrollment; per Infectious Diseases Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B [HB]sAg+, HBcore+, hepatitis B surface antibody [HBsAB] negative [-]) will be required to be on anti-hepatitis B therapy, during the study, in order to be eligible; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; if infected with hepatitis B, participants will be permitted to enroll in the study provided liver function tests meet criteria listed above, there is no evidence of cirrhosis AND participants will be required to be on anti-hepatitis B therapy
  • All participants will be required to be screened for hepatitis C; if hepatitis C antibody positive, with or without a positive hepatitis C RNA level, participants will be permitted to enroll in the study provided liver function tests meet criteria listed, and have no evidence of cirrhosis; participants diagnosed with hepatitis C less than 6 months from trial enrollment will be considered to have acute hepatitis C, and will be excluded from study UNLESS hepatitis C viral load is undetectable
  • Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multi-gated acquisition (MUGA) that is at or above the institutional normal limits
  • Participants must be able to swallow oral pills
  • Ability to understand and willing to sign a written informed consent document

Exclusion Criteria:

  • Participants who have had chemotherapy other than R-EPOCH or R-CHOP, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks
  • Prior cytotoxic chemotherapy or radiotherapy for this lymphoma
  • Rituximab within 12 months prior to study registration; only exception will be if rituximab was given for indications other than the treatment of aggressive lymphoma, or for one prior cycle of treatment
  • Participants who are receiving any other investigational agents
  • Participants who have previously received ibrutinib for another indication
  • Expected survival < 2 months
  • Participants with a history of an opportunistic fungal infection or active fungal infection requiring, or at high risk of requiring, prophylactic or treatment with fluconazole, voriconazole or posaconazole
  • Participants with known brain metastases from solid tumors should be excluded from this clinical trial
  • Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma (KS) that requires systemic therapy
  • In the dose-finding portion of the study, participants with known or suspected parenchymal brain, spinal cord, leptomeningeal disease prior to study enrollment will be excluded; in the dose-expansion portion of the study, known or suspected parenchymal brain or spinal cord disease, and/or suspected or symptomatic leptomeningeal disease prior to study enrollment will be excluded; asymptomatic leptomeningeal disease only will be allowed in the dose-expansion cohort
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnancy or breastfeeding; a pregnancy test must be performed within 7 days prior to ibrutinib initiation in women of childbearing potential; pregnant women; breastfeeding must be discontinued because of unknown but potential risks in the nursing infant
  • Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator
  • Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible
  • Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study entry; splenectomy will not be considered an exclusionary major surgery
  • History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past
  • Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities

Sites / Locations

  • UC San Diego Moores Cancer CenterRecruiting
  • UCLA / Jonsson Comprehensive Cancer CenterRecruiting
  • UCSF Medical Center-ParnassusRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
  • Memorial Hospital WestRecruiting
  • John H Stroger Jr Hospital of Cook CountyRecruiting
  • University of Illinois College of Medicine - ChicagoRecruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
  • Boston Medical CenterRecruiting
  • Siteman Cancer Center at Washington UniversityRecruiting
  • Washington University School of MedicineRecruiting
  • Montefiore Medical Center - Moses Campus
  • Mount Sinai HospitalRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • UNC Lineberger Comprehensive Cancer CenterRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Pennsylvania HospitalRecruiting
  • Fox Chase Cancer Center
  • Virginia Mason Medical CenterRecruiting
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (R-da-EPOCH)

Arm Description

Patients receive rituximab IV on day 1 (for CD20 positive patients only), etoposide IV over 96 hours on days 1-4, doxorubicin hydrochloride IV over 96 hours on days 1-4, vincristine sulfate IV over 96 hours on days 1-4, prednisone PO daily on days 1-5, cyclophosphamide IV over 1 hour on day 5, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC from 1 calendar day up to 48 hours or filgrastim SC beginning on day 6 for up to 10 days until ANC is satisfactory.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of ibrutinib in combination with chemotherapy
There will be no formal statistical testing for the dose-finding portion of the study.
Recommended phase II dose (RP2D) of ibrutinib in combination with chemotherapy
There will be no formal statistical testing for the dose-finding portion of the study.

Secondary Outcome Measures

Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0
Toxicity data will be presented by type and severity for each dose cohort. Incidence of toxicity related dose reductions and treatment discontinuations will be summarized for each dose group.
Complete response rates
The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH).
Progression free survival (PFS)
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Progression free survival (PFS)
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Overall survival (OS)
OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Overall survival (OS)
OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Lymphoma cell-of-origin (COO) assessment
Will be determined by gene expression profiling (GEP) (germinal center B-cell [GCB], activated B-cell [ABC], unclassifiable) and immunohistochemistry [IHC] (GCB, non-GCB). The concordances and discordances between classifications will be estimated with binomial proportions and their 95% corresponding confidence intervals. The response rates and survival as categorized by GEP or IHC will be compared, to see which analysis of COO best correlates with treatment response. Chi-square tests will be used to test the associations between 1) GEP (GCB, ABC, unclassifiable) with response rates and 2) IHC (GCB, non-GCB) with responses rate. The Kaplan Meier method will be used to calculate estimates of OS and PFS within GEP (GCB, ABC, unclassifiable) and within IHC (GCB, non-GCB), as well as their 95% confidence intervals. The log-rank test will be used to test differences with respect to OS and PFS within GEP and within IHC.
Percentage of participants who receive two or more cycles of combination chemotherapy, and are able to continue on a minimum dose level of cyclophosphamide of -1 and above after dose adjustments
Hematologic toxicities will be calculated.
Average number of days per cycle participants are able to stay on planned dose of ibrutinib
Average number of days will be calculated.
Changes in the levels of human immunodeficiency virus (HIV)-1 viral reservoirs
Descriptive statistics will be used to evaluate the changes and will be compared with treatment completion. If there are sufficient data, the binomial test of proportions will be used to test if the long term viral reservoir is either undetectable or below baseline in at least half of the participants.
Changes in Epstein-Barr virus (EBV) viral loads
Descriptive statistics will be used to evaluate the changes and compared with treatment completion. If there are sufficient data, the binomial test of proportions will be used to test if the long term viral reservoir is either undetectable or below baseline in at least half of the participants.
Effect of treatment on HIV latency reservoirs
Will be correlated with degree of ITK inhibition and Pearson or Spearman correlation coefficients will be used, as appropriate.
Effect of treatment on B-cell receptor signaling pathway including BTK activity
Descriptive statistics will be used.
Effect of treatment on T-cell receptor signaling via ITK activity.
Descriptive statistics will be used.
Soluble cytokine response to treatment
Descriptive statistics will be used.
Pharmacokinetics (PK) parameters assessment for ibrutinib, doxorubicin hydrochloride, etoposide, and vincristine sulfate
Relevant individual PK parameters will be estimated using non-compartmental or compartmental PK methods with the software WinNonlin. The PK variables will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) and compared across dose levels (if applicable) using nonparametric statistical testing techniques. PK parameters (i.e., steady state concentration [Css], clearance [Cl], and area under the curve [AUC]) will be correlated with pharmacodynamics effects using nonparametric statistical testing techniques.

Full Information

First Posted
July 17, 2017
Last Updated
September 12, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03220022
Brief Title
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas
Official Title
Phase I and Dose-Expansion Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) in participants with acquired immunodeficiency syndrome (AIDS)-related lymphomas (ARL). SECONDARY OBJECTIVES: I. To evaluate the complete response (CR) rates of ARL to ibrutinib and R-da-EPOCH. II. To measure the 1-year and 2-year overall and progression-free survival of participants with ARL treated with combination ibrutinib and R-da-EPOCH, including preliminary comparison of non-germinal center B-cell (GCB) with historical controls treated with R-da-EPOCH. III. To categorize and compare the cell-of-origin by gene expression profiling (GEP) gene expression-based classification (GCB, activated B-cell-like, unclassifiable) to immunohistochemistry (IHC) classification (GCB, non-GCB), estimate the discordant classification, and correlate each biological classification (IHC and GEP) with treatment response rates and survival. IV. To calculate the percentage of participants who receive two or more cycles of R-da-EPOCH, and are able to continue on a minimum dose level of cyclophosphamide of -1 and above after dose adjustments for hematologic toxicities. V. To determine the average number of days per cycle participants are able to stay on planned dose of ibrutinib at the recommended phase II dose (RP2D). VI. To assess the effect of ibrutinib and R-da-EPOCH on the human immunodeficiency virus (HIV) long-term latency reservoir. VII. To assess the effect and degree of ibrutinib and R-da-EPOCH on T-cell receptor signaling via ITK inhibition. VIII. To assess the effect of ibrutinib and R-da-EPOCH on B-cell receptor signaling pathway including BTK activity in ARL. IX. To evaluate the soluble cytokine response to ibrutinib and R-da-EPOCH. X. To characterize the pharmacokinetics of doxorubicin, etoposide, and vincristine in the presence of ibrutinib, and vice versa, and assess the clinical relevance of any drug-drug interaction and correlate with pharmacodynamics outcomes. OUTLINE: This is a dose escalation study of ibrutinib. Patients receive rituximab intravenously (IV) on day 1 (for CD20 positive patients only), etoposide IV over 96 hours on days 1-4, doxorubicin hydrochloride IV over 96 hours on days 1-4, vincristine sulfate IV over 96 hours on days 1-4, prednisone orally (PO) daily on days 1-5, cyclophosphamide IV over 1 hour on day 5, and ibrutinib PO once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim subcutaneously (SC) from 1 calendar day up to 48 hours or filgrastim SC beginning on day 6 for up to 10 days until absolute neutrophil count (ANC) is satisfactory. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS-Related Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (R-da-EPOCH)
Arm Type
Experimental
Arm Description
Patients receive rituximab IV on day 1 (for CD20 positive patients only), etoposide IV over 96 hours on days 1-4, doxorubicin hydrochloride IV over 96 hours on days 1-4, vincristine sulfate IV over 96 hours on days 1-4, prednisone PO daily on days 1-5, cyclophosphamide IV over 1 hour on day 5, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC from 1 calendar day up to 48 hours or filgrastim SC beginning on day 6 for up to 10 days until ANC is satisfactory.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, WR-138719
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride
Other Intervention Name(s)
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP16
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi, Filgrastim-ayow, Filgrastim-sndz, G-CSF, Granix, Neupogen, Neutroval, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tbo-filgrastim, Tevagrastim, XM02, Zarxio
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, Fulphila, HSP-130, Jinyouli, Neulasta, Neulastim, Neupopeg, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, Pegfilgrastim-jmdb, Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
.delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Intervention Description
Given PO
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Riabni, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, rituximab-abbs, Rituximab-arrx, Rituximab-pvvr, RTXM83, Ruxience, Truxima
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate
Other Intervention Name(s)
Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of ibrutinib in combination with chemotherapy
Description
There will be no formal statistical testing for the dose-finding portion of the study.
Time Frame
Up to 21 days
Title
Recommended phase II dose (RP2D) of ibrutinib in combination with chemotherapy
Description
There will be no formal statistical testing for the dose-finding portion of the study.
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0
Description
Toxicity data will be presented by type and severity for each dose cohort. Incidence of toxicity related dose reductions and treatment discontinuations will be summarized for each dose group.
Time Frame
Up to 5 years
Title
Complete response rates
Description
The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH).
Time Frame
Up to 5 years
Title
Progression free survival (PFS)
Description
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Time Frame
1 year
Title
Progression free survival (PFS)
Description
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Time Frame
2 years
Title
Overall survival (OS)
Description
OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Time Frame
1 year
Title
Overall survival (OS)
Description
OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
Time Frame
2 years
Title
Lymphoma cell-of-origin (COO) assessment
Description
Will be determined by gene expression profiling (GEP) (germinal center B-cell [GCB], activated B-cell [ABC], unclassifiable) and immunohistochemistry [IHC] (GCB, non-GCB). The concordances and discordances between classifications will be estimated with binomial proportions and their 95% corresponding confidence intervals. The response rates and survival as categorized by GEP or IHC will be compared, to see which analysis of COO best correlates with treatment response. Chi-square tests will be used to test the associations between 1) GEP (GCB, ABC, unclassifiable) with response rates and 2) IHC (GCB, non-GCB) with responses rate. The Kaplan Meier method will be used to calculate estimates of OS and PFS within GEP (GCB, ABC, unclassifiable) and within IHC (GCB, non-GCB), as well as their 95% confidence intervals. The log-rank test will be used to test differences with respect to OS and PFS within GEP and within IHC.
Time Frame
Up to 5 years
Title
Percentage of participants who receive two or more cycles of combination chemotherapy, and are able to continue on a minimum dose level of cyclophosphamide of -1 and above after dose adjustments
Description
Hematologic toxicities will be calculated.
Time Frame
Up to 5 years
Title
Average number of days per cycle participants are able to stay on planned dose of ibrutinib
Description
Average number of days will be calculated.
Time Frame
Up to 5 years
Title
Changes in the levels of human immunodeficiency virus (HIV)-1 viral reservoirs
Description
Descriptive statistics will be used to evaluate the changes and will be compared with treatment completion. If there are sufficient data, the binomial test of proportions will be used to test if the long term viral reservoir is either undetectable or below baseline in at least half of the participants.
Time Frame
Baseline up to 5 years
Title
Changes in Epstein-Barr virus (EBV) viral loads
Description
Descriptive statistics will be used to evaluate the changes and compared with treatment completion. If there are sufficient data, the binomial test of proportions will be used to test if the long term viral reservoir is either undetectable or below baseline in at least half of the participants.
Time Frame
Baseline up to 5 years
Title
Effect of treatment on HIV latency reservoirs
Description
Will be correlated with degree of ITK inhibition and Pearson or Spearman correlation coefficients will be used, as appropriate.
Time Frame
Up to 5 years
Title
Effect of treatment on B-cell receptor signaling pathway including BTK activity
Description
Descriptive statistics will be used.
Time Frame
Up to 5 years
Title
Effect of treatment on T-cell receptor signaling via ITK activity.
Description
Descriptive statistics will be used.
Time Frame
Up to 5 years
Title
Soluble cytokine response to treatment
Description
Descriptive statistics will be used.
Time Frame
Up to 5 years
Title
Pharmacokinetics (PK) parameters assessment for ibrutinib, doxorubicin hydrochloride, etoposide, and vincristine sulfate
Description
Relevant individual PK parameters will be estimated using non-compartmental or compartmental PK methods with the software WinNonlin. The PK variables will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) and compared across dose levels (if applicable) using nonparametric statistical testing techniques. PK parameters (i.e., steady state concentration [Css], clearance [Cl], and area under the curve [AUC]) will be correlated with pharmacodynamics effects using nonparametric statistical testing techniques.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive or negative diffuse large B-cell lymphoma (DLBCL) Tissue available from the diagnostic biopsy in the form of blocks, tissue cores, or slides available for submission to central pathology is required for all participants enrolled to this study; formalin-fixed paraffin-embedded tissue from diagnostic tissue is acceptable and recommended; submission of the institutional diagnostic slides is also preferred for all participants enrolled in the study Stage II-IV disease; participant will need measurable disease by computed tomography (CT) or positron emission tomography (PET) scans if enrolled in the dose-expansion cohort HIV positive; documentation of HIV-1 infection by means of any one of the following: Documentation of HIV diagnosis in the medical record by a licensed health care provider; Documentation of receipt of ART (at least three different medications) by a licensed health care provider (documentation may be a record of an antiretroviral therapy (ART) prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name); HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL; Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay NOTE: a "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay, which is required for all investigational food drug (IND) studies Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1) Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%) CD4 count >= 100 in the dose-finding cohort; once the dose-finding cohort is complete and if safety is established, participants with any CD4 count, including CD4 count < 100, will be allowed in the dose-escalation phase Absolute neutrophil count: >= 1,000/mm^3, unless decreased due to bone marrow involvement with lymphoma Platelets: >= 75,000/mm^3, unless decreased due to bone marrow involvement with lymphoma Total bilirubin: =< 1.5 institutional upper limit of normal (ULN); if potential due to lymphoma, the first cycle may be given without ibrutinib and if transaminitis and bilirubinemia improves to meet parameters, participant mat be enrolled on the clinical trial Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]): < 2 institutional ULN; if potentially due to lymphoma, the first cycle will be given without ibrutinib and if transaminitis and bilirubinemia improves to meet parameters, participant may be enrolled on trial Creatinine levels within normal institutional limits; or, creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal; unless decreased due to renal involvement by lymphoma Participants must not be on medications, including antiretroviral (ARV) regimens such as cobicistat, indinavir, or ritonavir, or agents with moderate or strong CYP3A4 inhibition; if on a moderate or strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to a qualifying regimen with the last dose of the strong CYP3A4 inhibitor taken at least one week before administration of ibrutinib Willingness of sexually active participants 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, 90 days after completion of ibrutinib, and 12 months after the last dose of rituximab, whichever comes last; 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) All participants will be required to be screened for hepatitis B; all participants who present with acute hepatitis B or show normal transaminases and are hepatitis B surface antigen (HBsAg) positive (+) and IgM+ for hepatitis core antigen will not be eligible for trial enrollment; per Infectious Diseases Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B [HB]sAg+, HBcore+, hepatitis B surface antibody [HBsAB] negative [-]) will be required to be on anti-hepatitis B therapy, during the study, in order to be eligible; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; if infected with hepatitis B, participants will be permitted to enroll in the study provided liver function tests meet criteria listed above, there is no evidence of cirrhosis AND participants will be required to be on anti-hepatitis B therapy All participants will be required to be screened for hepatitis C; if hepatitis C antibody positive, with or without a positive hepatitis C RNA level, participants will be permitted to enroll in the study provided liver function tests meet criteria listed, and have no evidence of cirrhosis; participants diagnosed with hepatitis C less than 6 months from trial enrollment will be considered to have acute hepatitis C, and will be excluded from study UNLESS hepatitis C viral load is undetectable Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multi-gated acquisition (MUGA) that is at or above the institutional normal limits Participants must be able to swallow oral pills Ability to understand and willing to sign a written informed consent document Exclusion Criteria: Participants who have had chemotherapy other than R-EPOCH or R-CHOP, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks Prior cytotoxic chemotherapy or radiotherapy for this lymphoma Rituximab within 12 months prior to study registration; only exception will be if rituximab was given for indications other than the treatment of aggressive lymphoma, or for one prior cycle of treatment Participants who are receiving any other investigational agents Participants who have previously received ibrutinib for another indication Expected survival < 2 months Participants with a history of an opportunistic fungal infection or active fungal infection requiring, or at high risk of requiring, prophylactic or treatment with fluconazole, voriconazole or posaconazole Participants with known brain metastases from solid tumors should be excluded from this clinical trial Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma (KS) that requires systemic therapy In the dose-finding portion of the study, participants with known or suspected parenchymal brain, spinal cord, leptomeningeal disease prior to study enrollment will be excluded; in the dose-expansion portion of the study, known or suspected parenchymal brain or spinal cord disease, and/or suspected or symptomatic leptomeningeal disease prior to study enrollment will be excluded; asymptomatic leptomeningeal disease only will be allowed in the dose-expansion cohort History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnancy or breastfeeding; a pregnancy test must be performed within 7 days prior to ibrutinib initiation in women of childbearing potential; pregnant women; breastfeeding must be discontinued because of unknown but potential risks in the nursing infant Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study entry; splenectomy will not be considered an exclusionary major surgery History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida C Wong-Sefidan
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald T. Mitsuyasu
Phone
310-825-6689
Email
rmitsuya@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Ronald T. Mitsuyasu
Facility Name
UCSF Medical Center-Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Sandoval-Sus
Phone
954-265-4325
Email
jsandovalsus@mhs.net
First Name & Middle Initial & Last Name & Degree
Jose Sandoval-Sus
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
University of Illinois College of Medicine - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul G. Rubinstein
Phone
312-996-5931
Email
paulgr@uic.edu
First Name & Middle Initial & Last Name & Degree
Paul G. Rubinstein
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Quillen
Phone
617-638-7828
Email
Karen.Quillen@bmc.org
First Name & Middle Initial & Last Name & Degree
Karen Quillen
Facility Name
Siteman Cancer Center at Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Ratner
Phone
314-747-7405
Email
lratner@wustl.edu
First Name & Middle Initial & Last Name & Degree
Lee Ratner
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suchitra Sundaram
Phone
212-824-7811
Email
suchitra.sundaram@mssm.edu
First Name & Middle Initial & Last Name & Degree
Suchitra Sundaram
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher E. Dittus
Phone
984-974-0000
Email
chris_dittus@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Christopher E. Dittus
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia A. Locantore-Ford
Phone
215-829-6088
Email
patricia.ford@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Patricia A. Locantore-Ford
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M. Aboulafia
Phone
206-223-6193
Email
hemda@vmmc.org
First Name & Middle Initial & Last Name & Degree
David M. Aboulafia
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Learn more about this trial

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

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