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Table 2 Ongoing clinical trials investigating venetoclax in combination with other agents for the treatment of hematological malignancies

From: BCL-2 as therapeutic target for hematological malignancies

Intervention Disease Study phase(s) Estimated* or actual** enrollment Register number in clinical trials.gov
V + ibrutinib + obinutuzumab MCL I/II 48* NCT02558816
V + ibrutinib MCL II 24* NCT02471391
V + ibrutinib R/R MCL I 28* NCT02419560
V + low-dose cytarabine Treatment-naïve AML I/II 94** NCT02287233
V + rituximab Relapsed CLL and SLL I 49** NCT01682616
V + bortezomib + dexamethasone R/R MM I 66** NCT01794507
V + bendamustine + obinutuzumab CLL II 66** NCT02401503
V + dexamethasone R/R MM t(11;14)-positive MM II 166* NCT01794520
V + bendamustine/rituximab R/R NHL I 60** NCT01594229
V + decitabine or azacitidine AML I 260* NCT02203773
V + obinutuzumab Untreated or R/R CLL I 82** NCT01685892
V + rituximab or obinutuzumab and standard doses of CHOP NHL I/II 267** NCT02055820
V + rituximab vs bendamustine + rituximab Relapsed/resistant CLL III 389** NCT02005471
V + bendamustine + rituximab vs BR alone R/R FL II 164** NCT02187861
V + bortezomib and dexamethasone R/R MM III 291** NCT02755597
V + bendamustine + rituximab or bendamustine and obinutuzumab R/R or untreated CLL I 84** NCT01671904
V + obinutuzumab + ibrutinib R/R or untreated CLL I/II 63** NCT02427451
V + obinutuzumab + vs obinutuzumab + chlorambucil CLL with coexisting medical conditions III 445** NCT02242942
V + azacitidine vs placebo + azacitidine Treatment-naïve AML III 400* NCT02993523
V + obinutuzumab R/R DLBCL II 21* NCT02987400
V + carfilzomib + dexamethasone R/R MM II 40* NCT02899052
V + ibrutinib R/R FL I/II 41* NCT02956382
V + ibrutinib CLL; SLL II 160* NCT02756897
V + obinutuzumab Untreated FL I 25* NCT02877550
V + lenalidomide + obinutuzumab R/R NHL I 60* NCT02992522
V + decitabine R/R AML II 160* NCT03404193
V + standard chemotherapy ALL I 22* NCT03319901
V with or without chemotherapy Pediatric and young adult R/R malignancies (ALL, AML, NHL, and other non-hematological tumors) I 135* NCT03236857
V + ibrutinib CLL/SLL with progressive disease on ibrutinib I 24* NCT03422393
V + obinutuzumab and bendamustine FL II 56* NCT03113422
V + dose-adjusted EPOCH-R Richter’s syndrome II 20* NCT03054896
V + navitoclax + chemotherapy R/R ALL I 42* NCT03181126
V + ibrutinib High-risk CLL; SLL II 45* NCT03128879
V + obinutuzumab, after different debulking regimens Untreated CLL   100* NCT03406156
V + ublituximab + umbralisib (TGR-1202) R/R CLL; SLL I/II 30* NCT03379051
V + TAK-659 R/R NHL I 53* NCT03357627
V + R-ICE R/R DLBCL I 18* NCT03064867
V + chemotherapy (FLAG-IDA) AML I/II 56* NCT03214562
V + low-dose cytarabine vs low-dose cytarabine Untreated AML III 175* NCT03069352
V + cobimetinib vs cobimetinib vs V + cobimetinib + atezolizumab R/R MM I/II 72* NCT03312530
V + rituximab vs bendamustine + rituximab R/R CLL III 389** NCT02005471
V + bendamustine, rituximab, and ibrutinib R/R MCL Early phase I 18* NCT03295240
V + ibrutinib R/R CLL/SLL II 20* NCT03045328
V + ibrutinib vs ibrutinib MCL III 287* NCT03112174
V + ibrutinib + obinutuzumab CLL patients with TP53 deletion (17p-) and/or mutation II 40* NCT02758665
V + ketoconazole R/R NHL I 12** NCT01969669
V + atezolizumab + obinutuzumab R/R FL, R/R agressive DLBCL, R/R indolent NHL II 138* NCT03276468
V + rituximab R/R CLL; SLL I 49** NCT01682616
V + ixazomib citrate + dexamethasone R/R MM I/II 71* NCT03399539
MOR00208 + V vs MOR00208 + idelalisib R/R CLL/SLL Patients pretreated with BTKi II 24* NCT02639910
V + cobimetinib and V + idasanutlin RR AML not eligible for cytotoxic therapy I/II 140* NCT02670044
V + DA-EPOCH-R Aggressive B-cell lymphomas (including DLBCL; HGBCL, TiNHL, and unclassifiable with intermediate features between DLBCL and BL) I 18* NCT03036904
V + ibrutinib R/R CLL with or without TP53 aberrations II 230* NCT03226301
V + ibrutinib Treatment naïve CLL/SLL II 289* NCT02910583
V + RO6870810, with or without rituximab R/R DLBCL I 94* NCT03255096
V + chemotherapy R/R AML or acute leukemia of ambiguous lineage I 54* NCT03194932
V or V + azatidine or V + rituximab AML, CLL, MM, NHL, SLL I/II 37* NCT02265731***
V + ibrutinib and rituximab R/R DLBCL I 30* NCT03136497
Obinutuzumab + idasanutlin and V or rituximab + idasanutlin and V R/R FL or R/R DLCBL I/II 140* NCT03135262
V + daratumumab and dexamethasone (with and without bortezomib) R/R MM II 90* NCT03314181
Obinutuzumab, rituximab, polatuzumab vedotin, and V R/R FL or DLBCL I 134* NCT02611323
Standard chemoimmunotherapy vs rituximab + V vs obinutuzumab + V vs obinutuzumab + Ibrutinib + V Fit patients with untreated CLL without del(17p) or TP53 mutation III 920* NCT02950051
V + ibrutinib + prednisone + obinutuzumab,+ Revlimid R/R B-cell lymphoma I 38* NCT03223610
  1. AML acute myelogenous leukemia; BL Burkitt lymphoma; CLL chronic lymphocytic lymphoma; DLBCL diffuse large B-cell lymphoma. FL follicular lymphoma; FLAG-IDA chemotherapy includes fludarabine, cytarabine, idarubicin, and filgrastim; HGBCL high-grade B-cell lymphoma; MCL mantle cell lymphoma; MM multiple myeloma; NHL non-Hodgkin lymphoma; RICE rituximab, ifosfamide, carboplatin, etoposide; R/R relapsed/refractory; SLL small lymphocytic lymphoma; TiNHL transformed indolent NHL; V venetoclax
  2. Results retrieved from the Clinical Trials database (www.clinicaltrial.gov) accessed at 20 Feb 2018 *Estimated enrollment at the time of Clinical Trials database access.**Actual enrollment at the time of Clinical Trials database access.
  3. The following studies were not included in this table: studies with status “withdrawn” (NCT03342678, NCT02640833, NCT01969682); studies on myelodysplasic syndromes, expanded access (NCT03123029), and post-marketing observational study (NCT03310190)
  4. Actual: recruitment status completed or active, not recruiting
  5. ***This trial has four arms of treatment: Arm A: phase I of venetoclax in monotherapy for R/R NHL or MM; Arm B: phase I of venetoclax in monotherapy in CLL/SLL; Arm C: phase 1 of venetoclax with the addition of azacitidine in participants AML; and Arm D: phase 2 of venetoclax with the addition of rituximab in R/R CLL