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)

Stopped early · Phase 1

Conditions studied: Lymphoma, Large B-Cell, Diffuse

In brief

This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.

Key facts

Study ID

NCT04790903

Run by

Hoffmann-La Roche

People needed

50

Starts

2021-07-02

Expected to finish

2024-05-21

Last updated by the study team

2024-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously untreated participants with CD20-positive DLBCL.
• BCL-2 protein overexpression by IHC, as assessed by local testing.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• International Prognostic Index (IPI) 2-5.
• Life expectancy of more than 6 months.
• Left ventricular ejection fraction (LVEF) ≥ 50%, as determined on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO).
• Availability of archival or freshly collected tumor tissue prior to study enrollment.
• At least one bi-dimensionally fluorodeoxyglucose-avid measurable lymphoma lesion on PET/CT scan, defined as > 1.5 cm in its longest dimension on CT scan.
• Adequate hematopoietic function.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

You may not qualify if…

• Current diagnosis of unclassifiable B-cell lymphoma.
• Prior treatment for indolent lymphoma.
• Current Grade > 1 peripheral neuropathy.
• Prior organ transplantation.
• Prior use of any monoclonal antibody within 3 months and any investigational therapy within 28 days prior to the start of Cycle 1.
• Vaccination with live vaccines within 28 days prior to the start of Cycle 1.
• Prior therapy for DLBCL and High-Grade B-cell Lymphoma (HGBCL) with the exception of palliative, short-term treatment with corticosteroids.
• Recent major surgery (within 6 weeks prior to the start of Day 1 of Cycle 1), other than for diagnosis.
• History of other cancers within 2 years prior to screening.
• Any active infection that, in the opinion of the investigator, would impact participant safety within 7 days prior to Day 1 of Cycle 1.
• Serious infection requiring oral or IV antibiotics within 4 weeks prior to Day 1 of Cycle 1.
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
• Positive test for Hepatitis B/C Viruses (HBV/HCV) and Human T-cell Leukemia Virus (HTLV)-1.
• Known infection with HIV.
• History of progressive multifocal leukoencephalopathy.
• Suspected active or latent tuberculosis.
• Clinically significant history of liver disease, including viral or other hepatitis or cirrhosis.
• Substance abuse, including non-prescription drug and alcohol dependence, within 12 months prior to screening.
• Pregnant or breastfeeding, or intending to become pregnant during the study within 6 months after the final dose of venetoclax, 9 months after the final dose of polatuzumab vedotin, or 12 months after the final dose of rituximab.
• History or presence of an abnormal ECG that is clinically significant in the investigator's opinion.
• Malabsorption syndrome or other condition that would interfere with enteral absorption.
• Blood transfusion within 14 days prior to screening.

Where it is running

• NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez — Lille, France
• CHU Montpellier - Saint ELOI — Montpellier, France
• CHU de Nantes; Cancéro-dermatologie — Nantes, France
• Hôpital Saint-Louis — Paris, France
• Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale — Pierre-Bénite, France
• CHU Rennes - Hopital Pontchaillou — Rennes, France
• Centre Henri Becquerel — Rouen, France
• Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica — Naples, Campania, Italy
• Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; Dip. Scienze Mediche e Chirurgiche — Bologna, Emilia-Romagna, Italy
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST; Farmacia Oncologica — Meldola, Emilia-Romagna, Italy
• Ospedale Santa Maria Delle Croci — Ravenna, Emilia-Romagna, Italy
• Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia — Pisa, Piedmont, Italy
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia — Barcelona, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital General Univ. Gregorio Maranon — Madrid, Spain
• Hospital Universitario La Fe; Servicio de Farmacia — Valencia, Spain

Full record on ClinicalTrials.gov

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