Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Untreated Aggressive Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04231877|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : April 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Aggressive Non-Hodgkin Lymphoma ALK-Positive Large B-Cell Lymphoma B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin 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 (Thymic) Large B-Cell Lymphoma T-Cell/Histiocyte-Rich Large B-Cell Lymphoma||Drug: Polatuzumab Vedotin Biological: Rituximab Drug: Prednisone Drug: Etoposide Drug: Doxorubicin Drug: Cyclophosphamide Biological: Filgrastim||Phase 1|
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.
After the completion of study treatment, patients are followed periodically for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (DA-EPCH-PR) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas|
|Actual Study Start Date :||October 27, 2020|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||April 1, 2023|
Experimental: Treatment (polatuzumab vedotin, combination chemotherapy)
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. Patients also receive filgrastim 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.
Drug: Polatuzumab Vedotin
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose of polatuzumab or first administration of alternate therapy ]Will estimate the safety and tolerability of polatuzumab vedotin when added to dose-adjusted-etoposide, prednisone, vincristine (Oncovin), cyclophosphamide, doxorubicin-rituximab (DA-EPCH-R) chemoimmunotherapy.
- The proportion of patients who are unable to complete 6 cycles of therapy for reasons other than disease progression [ Time Frame: Up to 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231877
|Contact: Ryan Lynchfirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ryan Lynch 206-606-1739 email@example.com|
|Principal Investigator: Ryan Lynch|
|Principal Investigator:||Ryan Lynch||Fred Hutch/University of Washington Cancer Consortium|