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)

  • STATUS
    Recruiting
  • End date
    Feb 12, 2025
  • participants needed
    50
  • sponsor
    Hoffmann-La Roche
Updated on 28 July 2022

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.

Details
Condition Lymphoma, Large B-Cell, Diffuse
Treatment Rituximab, cyclophosphamide, prednisone, doxorubicin, venetoclax, Polatuzumab Vedotin
Clinical Study IdentifierNCT04790903
SponsorHoffmann-La Roche
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

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 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
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