Skip to main content

Table 1 Clinical trials of ibrutinib monotherapy in B-cell lymphoma

From: Ibrutinib in B-cell lymphoma: single fighter might be enough?

Disease

Study (year)

Phase

Study details

Efficacy

Refs.

TN CLL

Byrd et al. (2018)

Ib/II

7-year follow up, 31 pts

ORR 87%, PFS 80%, OS 75%

[13]

 

O’Brien et al. (2014)

Ib/II

31 elderly pts

Objective response 71%, CR 13%, PR 55%

[15]

 

Burger et al. (2015)

III

269 elderly pts to compare ibrutinib with chloramnucil

ORR (86% vs. 35%), 18.4-month PFS (not reached vs. 18.9 months); 24-month OS (98% vs. 85%)

[39]

R/R CLL

Byrd et al. (2018)

Ib/II

7-year follow up, 101 pts

ORR 89%, PFS 32%, OS 52%

[13]

 

Jones et al. (2018)

III

230 pts with del17p

30-month PFS 57%, OS 69%

[1]

 

Byrd et al. (2013)

Ib/II

85 pts, the majority of whom were considered to have high-risk disease, 51 received 420 mg, 34 received 840 mg

ORR (71% vs. 71%), PR with lymphocytosis (20% vs. 15%), 24-month OS and PFS were 83% and 75%

[11]

 

O’Brien et al. (2016)

II

145 pts with del17p

ORR 83%, 26-month PFS 63%, 26-month OS 75%,

[12]

 

Byrd et al. (2014)

III

391 pts at risk for a poor outcome, to compare ibrutinib with ofatumumab

ORR (42.6% vs. 4.1%), PFS 88% and PR with lymphocytosis of ibrutinib group was 20%, 12-month OS (90% vs. 81%)

[14]

R/R MCL

Jeon et al. (2019)

NA

33 pts

ORR 33%, OS 35.1 months, PFS 27.4 months

[21]

 

Wang et al. (2015)

II

Long-term follow up of 111 pts, at a dose of 560 mg once daily

ORR 67%, CR 23%, 24-month OS 47%, 24-month PFS 31%

[17]

 

Dreyling et al. (2016)

III

280 pts to compare ibrutinib (n = 139) with temsirolimus (n = 141)

ORR (72% vs. 40%), CR with ibrutinib was 19%, median PFS (14.6 vs. 6.2 months), OS (not reached vs. 21.3 months)

[19]

R/R FL

Advani et al. (2013)

I

56 pts

ORR 38%

[29]

 

Bartlett et al. (2017)

II

40 pts with ibrutinib 560 mg once daily

ORR 37.5%, CR 12.5%, 2-year PFS 20.4%, median PFS 14 months

[30]

R/R ABC-DLBCL

Wilson et al. (2017)

I/II

38 pts

CR or PR 37%

[32]

PCNSL

Grommes et al. (2017)

I

13 pts

ORR 77%

[34]

 

Lionakis et al. (2017)

Ib

18 pts

PR 83%

[35]

R/R WM

Dimopoulos et al. (2016)

III

31 rituximab- refractory pts with a dose of 420 mg

ORR 90%, MRR 71%, OS 97%, PFS 86%

[44]

 

Treon et al. (2015)

II

63 pts with ibrutinib 420 mg once daily

ORR 90.5%, MRR 73%, PFS 69.1%, OS 95.2%

[25]

R/R MZL

Noy et al. (2016)

II

63 pts with ibrutinib 560 mg once daily

ORR 48% (6 CRs, 26 PRs)

[28]

  1. Pts, Patients; DLBCL, Diffuse large B-cell lymphoma; ABC, Activated B-cell like; non-GCB, Germinal center B cell-like; CLL/SLL, Chronic lymphocytic leukemia/small lymphocytic lymphoma; WM, Waldenstroms macroglobulinemia; FL, Follicular lymphoma; MCL, Mantle cell lymphoma; MZL, Marginal zone lymphoma; PFS, Progression-free survival; PR, Partial response; ORR, Overall response rate; MRR, Major response rate; R/R, Relapsed/refractory; TN, Treatment-native; del17p, 17p deletion; At risk for a poor outcome, A short duration of response to therapy or adverse cytogenetic abnormalities; High-risk, Pts with del17p, del11q or with TP53 mutations.