Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2031-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin 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. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492

Diffuse Large B-Cell Lymphoma

ACTIVE_NOT_RECRUITING PHASE3

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

NCT04479267

Diffuse Large B-Cell Lymphoma High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements +2 more

ACTIVE_NOT_RECRUITING PHASE2

A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

NCT01992653

Lymphoma, Non Hodgkin

COMPLETED PHASE1/PHASE2

A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1

NCT07034508

DLBCL - Diffuse Large B Cell Lymphoma

NOT_YET_RECRUITING PHASE2

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080

Large B-Cell Lymphoma

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A (CLOSED TO ACCRUAL 05/23/2024): Patients receive rituximab intravenously (IV) on day 1, polatuzumab vedotin IV on day 1, prednisone orally (PO) twice daily (BID) on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Patients also receive filgrastim subcutaneously (SC) 24-72 hours after the last dose of each treatment cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo multigated acquisition (MUGA) scan or echocardiography during screening and fludeoxyglucose (FDG) positron emission tomography (PET), computed tomography (CT) scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.

ARM B: Patients receive rituximab IV on day 1, polatuzumab vedotin IV on day 1, prednisone PO BID on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Starting with cycle 2, patients also receive glofitamab, over 4 hours, on day 1 and 8 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and FDG PET, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.

After the completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aggressive Non-Hodgkin Lymphoma ALK-Positive Large B-Cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements High Grade B-Cell Lymphoma, Not Otherwise Specified Primary Mediastinal Large B-Cell Lymphoma T-Cell/Histiocyte-Rich Large B-Cell Lymphoma Gray-Zone Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

1313206-42-6 ADC DCDS4501A Antibody-Drug Conjugate DCDS4501A DCDS4501A FCU 2711 polatuzumab vedotin-piiq Polivy RG7596 Ro 5541077-000 174722-31-7 687451 ABP 798 C2B8 Monoclonal Antibody Chimeric Anti-CD20 Antibody IDEC-C2B8 Monoclonal Antibody Rituxan Rituximab ABBS Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 rituximab-abbs Rituximab Biosimilar SIBP-02 Riabni Rituximab ARRX Rituximab PVVR Ruxience 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Metacortandracin Meticorten Ofisolona Panafcort Paracort Predicor Predicorten Prednidib Prednilonga Prednitone Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamide Monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Glofitamab-gxbm RO7082859 MUGA Scan MUGA EC FDG-PET FDG-PET Imaging CAT Scan CT Scan Computed Axial Tomography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Untreated aggressive B-cell large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to rituximab-cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine (Oncovin), prednisone (R-CHOP) and in the opinion of the investigator would be treated with DA-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. Composite lymphomas are not excluded provided that the subject has not receive prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:

* High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
* High grade B-cell lymphoma, not otherwise specified (NOS)
* Diffuse large B-cell lymphoma (DLBCL) NOS
* Primary mediastinal B-cell lymphoma
* T-cell/histiocyte-rich large-B-cell lymphoma
* Epstein-Barr virus (EBV) + DLBCL, NOS
* ALK+ large B-cell lymphoma (must be CD20+)
* B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
* Be willing and able to provide written informed consent for the trial
* Be \>= 18 years of age on day of signing informed consent
* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on computed tomography (CT) or fluorodeoxyglucose-positron emission tomography (FDG-PET)
* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)
* Left ventricular ejection fraction (LVEF) \>= 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Absolute neutrophil count (ANC) \>= 1,000/uL except in cases of marrow infiltration by lymphoma
* Platelets \>= 75,000 / mcL except in cases of marrow infiltration by lymphoma or hypersplenism
* Hemoglobin \>= 8 g/dL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment
* Measured or calculated creatinine clearance (Glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 40 mL/min.

\* Creatinine clearance should be calculated per institutional standard
* Serum total bilirubin =\< 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin =\< 3.0 x ULN)
* Direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X ULN OR =\< 5 X ULN for subjects with liver involvement
* International Normalized Ratio (INR) or Prothrombin Time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
* Activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, or subject is shown to have an antiphospholipid antibody on workup
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of =\< 1% per year during the treatment period and for at least 12 months after the last dose of EPCH-R, 9 months after the last dose of polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 3 months after the last dose of tocilizumab (if applicable), whichever is longer. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (=\<12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of =\<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of EPCH-R or polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 2 months after the last dose of tocilizumab (if applicable), whichever is longer. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment
* ARM B ONLY: Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment

Exclusion Criteria

* Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
* Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.
* Richter's transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion 1
* Diagnosis of Burkitt lymphoma
* Prior organ transplantation
* Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
* Prior systemic therapy for indolent lymphoma
* Prior use of any monoclonal antibody within 3 months of the start of cycle 1; any investigational therapy within 28 days prior to the start of cycle 1; vaccination with live vaccines within 28 days prior the start of cycle 1 and at any time during the study treatment period
* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment) If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \> 30-100 mg/day of prednisone or equivalent. Prednisone \> 30-100 mg/day or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll
* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:

* Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible
* Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \>= 2 years prior to enrollment are eligible
* Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis
* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology):

\* Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard
* Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)

\* Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
* History of uncontrolled human immunodeficiency virus (HIV)

\* Patients with known diagnosis of HIV must have undetectable viral load, have a CD4 count ≥ 200/μL, and be on anti-retroviral therapy. HIV positive patients should be monitored per local/institutional standards while receiving study treatment
* Patients with a history of progressive multifocal leukoencephalopathy
* Pregnancy or lactation or intending to become pregnant during study
* ARM B ONLY: Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* ARM B ONLY: Known or suspected chronic active Epstein-Barr virus infection
* ARM B ONLY: Current or past history of Waldenström macroglobulinemia
* ARM B ONLY: Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, CNS lymphoma or neurodegenerative disease
* ARM B ONLY: Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed
* ARM B ONLY: Active autoimmune disease which is not well controlled by therapy
* ARM B ONLY: Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible
* ARM B ONLY: Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
* ARM B ONLY: Participants with active autoimmune disease with dermatologic manifestations are eligible for the study
* ARM B ONLY: Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded
* ARM B ONLY: Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months
* ARM B ONLY: Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* ARM B ONLY: Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
* ARM B ONLY: Grade 3 infection within 4 weeks of treatment initiation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan Lynch

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ryan Lynch

Role: CONTACT

[email protected]

206-606-1739

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ryan Lynch

Role: primary

[email protected]

206-606-1739

References

Explore related publications, articles, or registry entries linked to this study.

Lynch RC, Poh C, Ujjani CS, Warren EH, Smith SD, Shadman M, Morris K, Lee S, Rasmussen H, Ottemiller S, Shelby M, Keo S, Verni K, Kurtz DM, Alizadeh AA, Chabon JJ, Hogan GJ, Schulz A, Gooley T, Voutsinas JM, Gopal AK. Polatuzumab vedotin with infusional chemotherapy for untreated aggressive B-cell non-Hodgkin lymphomas. Blood Adv. 2023 Jun 13;7(11):2449-2458. doi: 10.1182/bloodadvances.2022009145.

Reference Type DERIVED

PMID: 36521030 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2019-08983

Identifier Type: REGISTRY

Identifier Source: secondary_id

10423

Identifier Type: OTHER

Identifier Source: secondary_id

RG1006477

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT05498220 ACTIVE_NOT_RECRUITING PHASE2

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

NCT05798156 ACTIVE_NOT_RECRUITING PHASE2

A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL

NCT04594798 ACTIVE_NOT_RECRUITING PHASE2

Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation

NCT07001540 RECRUITING PHASE2

An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

NCT03533283 ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT01925612 TERMINATED PHASE2

Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

NCT04491370 UNKNOWN PHASE1/PHASE2

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658 COMPLETED PHASE2

ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma

NCT07098364 RECRUITING PHASE1/PHASE2

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas

NCT01805037 TERMINATED PHASE1/PHASE2

A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL

NCT03467373 COMPLETED PHASE1

PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy

NCT04745949 RECRUITING PHASE2

A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

NCT01691898 COMPLETED PHASE1/PHASE2

A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin

NCT04624893 UNKNOWN

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

NCT06890884 RECRUITING PHASE2

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04790903 TERMINATED PHASE1

Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies

NCT01921387 COMPLETED PHASE1/PHASE2

Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04665765 ACTIVE_NOT_RECRUITING PHASE2

A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT02729896 COMPLETED PHASE1/PHASE2

Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma

NCT01539174 WITHDRAWN PHASE2

Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

NCT06594939 NOT_YET_RECRUITING PHASE2

Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

NCT00118209 COMPLETED PHASE3

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

NCT03671018 ACTIVE_NOT_RECRUITING PHASE1/PHASE2

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

NCT00070018 COMPLETED PHASE2

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

NCT00006721 ACTIVE_NOT_RECRUITING PHASE3

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

Study Results

Basic Information

Brief Summary

Related Clinical Trials

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Detailed Description

Conditions

Study Design

Study Groups

Arm A (polatuzumab vedotin, chemotherapy) [CLOSED TO ACCRUAL 05/23/2024]

Polatuzumab Vedotin

Rituximab

Prednisone

Etoposide

Doxorubicin

Cyclophosphamide

Multigated Acquisition Scan

Echocardiography

FDG-Positron Emission Tomography

Computed Tomography

Bone Marrow Biopsy

Biospecimen Collection

Bone Marrow Aspiration

Arm B (polatuzumab vedotin, glofitamab, chemotherapy)

Polatuzumab Vedotin

Rituximab

Prednisone

Etoposide

Doxorubicin

Cyclophosphamide

Glofitamab

Multigated Acquisition Scan

Echocardiography

FDG-Positron Emission Tomography

Computed Tomography

Bone Marrow Biopsy

Biospecimen Collection

Bone Marrow Aspiration

Interventions