Table 5.
Summary of clinical trials of zanubrutinib in hematologic malignancies listed in ClinicalTrials.gov as currently enrolling patients as of 30 September 2021.
| Trial identifier a | Phase | Sites | N | Line | Indication | Key inclusions/exclusions | Treatment | Est. primary completion date |
|---|---|---|---|---|---|---|---|---|
| Global | ||||||||
| NCT0333633363
SEQUOIA BGB-3111-304 |
3 | 160 | 710 | TN | CLL/SLL | Must be either age ⩾ 65 years or unsuitable for FCR | No del(17p): zanu versus BR (Arms A&B) Del(17p): zanu (Arm C); zanu + V (Arm D) |
10/2021 |
| NCT04002297
79
MANGROVE BGB-3111-306 |
3 | 122 | 500 | TN | MCL | Must be age ⩾ 65 years and transplant ineligible | Zanu + R versus BR | 9/2021 |
| NCT02914938 ME-401-002 |
1 | 24 | 177 | R/R | CLL/SLL, DLBCL, FL, MCL, MZL, high-grade NHL | No prior PI3K inhibitor No prior BTKi unless progressing or intolerant |
ME0401, ME-401 + zanu, ME-401 + R | 9/2021 |
| Asia/Pacific | ||||||||
| NCT04277637 BGB-11417-101 |
1 | 4 | 284 | R/R | CLL/SLL, DLBCL, FL, MCL, MZL, WM | No prior Bcl-2 inhibitor | BGB-11417 ± zanu | 8/2023 |
| NCT04282018 BGB-A317-3111-10188-101 |
1/2 | 6 | 150 | R/R | R/R CLL/SLL, FL, MCL, MZL, DLBCL |
No prior PI3k inhibitor | BGB-10188 ± zanu | 3/2025 |
| NCT04938297 ZR2 |
2 | 1 | 100 | TN R/R |
CNSL, DLBCL | No prior BTKi or len treatment | Zanu + len + R induction; then len or zanu maintenance |
10/2022 |
| NCT04436107 BGB-3111-110 |
1 | 10 | 67 | R/R | DLBCL | Must have prior CD20 and anthracycline treatment | Zanu + len ± R | 8/2022 |
| NCT04668365 HNSZLYYNHL05 |
2 | 1 | 59 | TN R/R |
DLBCL | Must have high-risk disease | Zanu + R-CHOP (TN); zanu + GemOx/DHAP/ICE/GDP, then maintenance zanu (R/R) |
12/2023 |
| NCT04463953 BDH-WM2020/4 |
2 | 1 | 55 | TN | WM | Patient must not have undergone standard treatment | Zanu + ixa + dexa | 5/2023 |
| NCT04172246 BGB-3111-211 |
1/2 | 15 | 53 | R/R | CLL/SLL, MCL, FL, MZL, and WM | – | Zanu | 7/2022 |
| NCT04736914 BGB-3111-2002-IIT |
2 | 1 | 47 | TN | MCL | Age 18–65 years, suitable for high-dose Ara-C | Zanu + R-CHOP or R-DHAOx (induction), ASCT, zanu (maintenance) | 1/2023 |
| NCT04624958 B2020-232-01 |
2 | 3 | 42 | TN | MCL | – | Zanu + R (induction); R-DHAOx (consolidation); zanu (maintenance) | 12/2025 |
| NCT04899453 PUMCH-NHL-007 |
2 | 1 | 42 | TN | PVRL | – | Zanu + R + MTX | 8/2022 |
| NCT04705129 RJ-PMBCL-1 |
2 | 1 | 40 | R/R | PMBCL, EBV + DLBCL NOS | Must have prior R, anthracycline therapies | Zanu + tislelizumab | 1/2023 |
| NCT04460248 ZR2 |
2 | 1 | 40 | TN | DLBCL | Must be age ⩾ 75 years unsuitable or unwilling to undergo CT | Zanu + len + R | 8/2021 |
| NCT04835870 ZR-CHOP |
2 | 1 | 20 | TN | Non-GCB DLBCL | – | Zanu + R-CHOP | 1/2024 |
| NCT04899570 PUMCH-NHL-008 |
2 | 1 | 20 | TN | IVLCL | – | Zanu + R-CHOP | 4/2023 |
| Europe | ||||||||
| NCT04271956 CLL-RT1 |
2 | 12 | 48 | R/R | CLL with RT | Must have < 2 prior treatments, not primary progressive | Zanu + tislelizumab | 8/2022 |
| NCT04515238 CLL2-BZAG |
2 | 2 | 40 | R/R | CLL | No prior progression on V or a BTKi | B (debulking), then zanu + GV induction and maintenance | 10/2022 |
| North America | ||||||||
| NCT03824483 BOVen 18-427 |
2 | 7 | 77 | TN | CLL/SLL, MCL | For MCL, must have TP53 mutation | Zanu + G + V | 2/2022 |
| NCT04116437 BGB-3111-215 |
2 | 29 | 90 | R/R | CLL/SLL, MCL, MZL, WM | Must be intolerant to prior ibr or acala | Zanu | 6/2025 |
| NCT04458610 NCI-2020-05053 |
2 | 1 | 60 | TN | CLL/SLL | – | Zanu + R | 5/2022 |
Ab, antibody; acala, acalabrutinib; B, bendamustine; BR, bendamustine and rituximab; BTKi, Bruton tyrosine kinase inhibitor; CHOP, cyclophosphamide, doxorubicin, vincristine and prednisone; CLL, chronic lymphocytic leukemia; CNSL, central nervous system lymphoma; CT, chemotherapy; dexa, dexamethasone; DHAOx, dexamethasone high-dose cytarabine, and oxaliplatin; DLBCL, diffuse large B-cell lymphoma; EBV, Epstein–Barr virus; FCR, fludarabine, cyclophosphamide, and rituximab; FL, follicular lymphoma; G, obinutuzumab; GCB, germinal center B-cell; GDP, gemcitabine, dexamethasone, and cisplatin; GemOx, gemcitabine and oxaliplatin; ibr, ibrutinib; ICE, ifosfamide, carboplatin, and etoposide; IVLCL, intravascular large B-cell lymphoma; ixa, ixazomib; len, lenalidomide; MCL, mantle cell lymphoma; MTX, methotrexate; MZL, marginal zone lymphoma; N, projected enrollment; NHL, non-Hodgkin lymphoma; NOS, not otherwise specified; PMBCL, primary mediastinal large B-cell lymphoma; PVRL, primary vitreoretinal lymphoma; R, rituximab; R/R, relapsed or refractory; RT, Richter transformation; SLL, small lymphocytic lymphoma; TN, treatment naïve; V, venetoclax; WM, Waldenström macroglobulinemia; Zanu, zanubrutinib.
Phase 1 pharmacokinetics trials were excluded. Trials are ordered by geographical region and projected numbers of patients. For more complete information, consult http://clinicaltrials.gov.