drugset

drugset / Trial / NCT03036904

Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas

NCT03036904 ↗

Phase 1 Completed 31 enrolled Weill Medical College of Cornell University Genentech, Inc. · collab M.D. Anderson Cancer Center · collab Massachusetts General Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.

Timeline

Start: 2017-02-06
Primary completion: 2021-11-11
Completion: 2021-11-11

Publications

Rutherford SC, Abramson JS, Bartlett NL, Barta SK, Khan N, Joyce R, Maddocks K, Ali-Shaw T, Senese S, Yuan Y, Westin J, Leonard JP. Venetoclax with dose-adjusted EPOCH-R as initial therapy for patients with aggressive B-cell lymphoma: a single-arm, multicentre, phase 1 study. Lancet Haematol. 2021 Nov;8(11):e818-e827. doi: 10.1016/S2352-3026(21)00273-8. Epub 2021 Oct 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	400 mg	Oral
Subject	Venetoclax	Small molecule	600 mg	Oral
Subject	Venetoclax	Small molecule	800 mg	Oral
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	10 mg/m2	Intravenous
Background	Etoposide	Small molecule	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	60 mg/m2	Oral
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Vincristine	Small molecule	0.4 mg/m2	Intravenous

Indications