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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)
- Cancer
- Non-Hodgkin's Lymphoma
- Diffuse Large B-Cell Lymphoma
- Lymphoma
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Cities
- Barcelona
- Bologna
- Lille
- Madrid
- Meldola
- Montpellier
- Nantes
- Napoli
- New York
- Pamplona
- Paris
- Pierre-Bénite
- Pisa
- Ravenna
- Rennes
- Rouen
- València
Trial Identifier:
NCT04790903 2020-002376-12 BO42203
Trial Summary
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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT04790903,BO42203,2020-002376-12
Trial Identifier
Venetoclax, Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
Treatments
Lymphoma, Large B-Cell, Diffuse
Condition
Official Title
A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
For the latest version of this information please go to www.forpatients.roche.com