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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