Table 2. PI3Ki combinations with... | American Society of Hematology

Table 2.

PI3Ki combinations with venetoclax with or without anti-CD20 monoclonal antibodies in patients with R/R CLL

Trial phase	Treatment	No. of patients	TP53 aberrations	Schedule	Strategy	uMRD rate	Discontinuation rate	Median follow-up
Phase I/II⁴⁶	Umbralisib-venetoclax-obinutuzumab	21	38%*	UMBRA cycle 1-12 + UBLI cycles 1-3 + VEN cycles 4-12	BM uMRD at cycle 12, discontinue all therapy BM MRD-positive at cycle 12, continue UMBRA monotherapy	4 patients with BM uMRD (19%)	4.7%	4.2 mo
Phase I⁴⁷	Duvelisib-venetoclax	12	25% del(17p) and 42% TP53 mutation	DUV days 1-7, then DUV+VEN for 12 cycles	uMRD on 2 assessments, discontinue all therapy; resume VEN monotherapy at MRD recrudescence MRD-positive, continue VEN monotherapy	22% uMRD in BM and PB	25%	Reported with median number of cycles 6 (range, 1-9)

Trial phase	Treatment	No. of patients	TP53 aberrations	Schedule	Strategy	uMRD rate	Discontinuation rate	Median follow-up
Phase I/II⁴⁶	Umbralisib-venetoclax-obinutuzumab	21	38%*	UMBRA cycle 1-12 + UBLI cycles 1-3 + VEN cycles 4-12	BM uMRD at cycle 12, discontinue all therapy BM MRD-positive at cycle 12, continue UMBRA monotherapy	4 patients with BM uMRD (19%)	4.7%	4.2 mo
Phase I⁴⁷	Duvelisib-venetoclax	12	25% del(17p) and 42% TP53 mutation	DUV days 1-7, then DUV+VEN for 12 cycles	uMRD on 2 assessments, discontinue all therapy; resume VEN monotherapy at MRD recrudescence MRD-positive, continue VEN monotherapy	22% uMRD in BM and PB	25%	Reported with median number of cycles 6 (range, 1-9)

BM, bone marrow; c, cycles; DUV, duvelisib; PB, peripheral blood; UBLI, ublituximab; UMBRA, umbralisib; VEN, venetoclax.

Also includes patients with del(11q).