Patient demographics, baseline disease characteristics, efficacy, and safety outcomes
| Patient . | Age, y . | Sex . | Prior lines of therapy for DLBCL . | Stage at study entry . | IPI at study entry . | Disease status . | Bridging therapy . | Duration of bridging therapy, d* . | LD chemo . | BOR . | Response at last follow-up . | DOR, d† . | DOR censoring event . | Survival status . | CRS . | CRS duration, d . | NT . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 54 | F | 1. R-CHOP with CR for ∼6 mo | III | ≥2 | Relapsed to last line | 1. Rituximab + cisplatin + gemcitabine | 129 | FluCy | CR | CR | 384 | Ongoing without event | Alive | No | — | No |
| 2. R-ICE → R-GDP → BEAM → HSCT with relapse 3 mo after transplant | 2. Rituximab + bendamustine | ||||||||||||||||
| 2 | 62 | F | 1. R-EPOCH with CR for ∼4 mo | IV | ≥2 | Relapsed to last line | 1. Cyclophosphamide + rituximab | 3 | FluCy | CR | CR | 351 | Ongoing without event | Alive | Grade 2 | 4 | No |
| 2. R-DHAP → azacitidine + vorinostat + busulfan + gemcitabine + melphalan (conditioning) → HSCT with CR for ∼2 y | |||||||||||||||||
| 3 | 68 | M | 1. CHOP with CR for ∼15 y | I | <2 | Relapsed to last line | 1. Rituximab + bendamustine | 2 | FluCy | CR | CR | 340 | Ongoing without event | Alive | Grade 3 | 7 | No |
| 2. R-CHOP with CR for ∼3 y | |||||||||||||||||
| 3. R-ICE with PR for ∼3 y | |||||||||||||||||
| 4 | 58 | F | 1. R-CHOP with CR for ∼4 y | I | <2 | Relapsed to last line | 1. Trofosfamide | 60 | FluCy | CR | CR | 324 | Ongoing without event | Alive | No | — | No |
| 2. R-DHAP → ofatumumab + ICE → BEAM → HSCT with CR for ∼2 y | 2. Ofatumumab + gemcitabine + liposomal doxorubicin + vinorelbine | ||||||||||||||||
| 5 | 68 | F | 1. R-CHOP with CR for ∼1.5 y | I | <2 | Relapsed to last line | 1. Rituximab + bendamustine | 2 | FluCy | CR | PD at day 274 | 246 | New anticancer therapy other than HSCT | Died day 544, DLBCL | Grade 3 | 5 | Dysphagia grade 1 |
| 2. Rituximab + methotrexate + etoposide + ifosfamide with CR for ∼11 mo | |||||||||||||||||
| 6 | 64 | F | 1. R-CHOP + methotrexate with CR for ∼4 mo | IV | ≥2 | Relapsed to last line | 1. Rituximab + methotrexate + cytarabine | 71 | FluCy | CR | PD at day 196 | 165 | Withdrew consent | Lost to follow-up | No | — | No |
| 2. R-ICE with SD for ∼1 mo | |||||||||||||||||
| 3. Rituximab + methotrexate + cytarabine + methylprednisolone → busulfan + etoposide + cyclophosphamide (conditioning) → HSCT with CR for 4 mo | |||||||||||||||||
| 7 | 71 | F | 1. R-EPOCH with CR for ∼7 mo | III | ≥2 | Relapsed to last line | 1. Ifosfamide + carboplatin + etoposide | 24 | FluCy | CR | CR | 65 | Adequate assessment no longer available | Alive | Grade 2 | 12 | No |
| 2. R-GDP with PR for ∼3 mo | |||||||||||||||||
| Overall JULIET population5 | |||||||||||||||||
| 56 | 35.5% F | 1: 5% | I: 7% | <2 risk factors: 27.9% | Relapse: 45% | 92% | 56 | 93% (FluCy: 73%; bendamustine: 20%) | 40% CR | — | — | — | 90% OS rate at 12 mo in patientts with CR | 22% grade 3/4 | — | 12% grade 3/4 | |
| 64.5% M | 2: 44% | II: 17% | 12% PR | ||||||||||||||
| 3: 31% | III: 20% | ≥2 risk factors: 72.1% | Refractory: 55% | ||||||||||||||
| 4-6: 21% | IV: 56% |
| Patient . | Age, y . | Sex . | Prior lines of therapy for DLBCL . | Stage at study entry . | IPI at study entry . | Disease status . | Bridging therapy . | Duration of bridging therapy, d* . | LD chemo . | BOR . | Response at last follow-up . | DOR, d† . | DOR censoring event . | Survival status . | CRS . | CRS duration, d . | NT . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 54 | F | 1. R-CHOP with CR for ∼6 mo | III | ≥2 | Relapsed to last line | 1. Rituximab + cisplatin + gemcitabine | 129 | FluCy | CR | CR | 384 | Ongoing without event | Alive | No | — | No |
| 2. R-ICE → R-GDP → BEAM → HSCT with relapse 3 mo after transplant | 2. Rituximab + bendamustine | ||||||||||||||||
| 2 | 62 | F | 1. R-EPOCH with CR for ∼4 mo | IV | ≥2 | Relapsed to last line | 1. Cyclophosphamide + rituximab | 3 | FluCy | CR | CR | 351 | Ongoing without event | Alive | Grade 2 | 4 | No |
| 2. R-DHAP → azacitidine + vorinostat + busulfan + gemcitabine + melphalan (conditioning) → HSCT with CR for ∼2 y | |||||||||||||||||
| 3 | 68 | M | 1. CHOP with CR for ∼15 y | I | <2 | Relapsed to last line | 1. Rituximab + bendamustine | 2 | FluCy | CR | CR | 340 | Ongoing without event | Alive | Grade 3 | 7 | No |
| 2. R-CHOP with CR for ∼3 y | |||||||||||||||||
| 3. R-ICE with PR for ∼3 y | |||||||||||||||||
| 4 | 58 | F | 1. R-CHOP with CR for ∼4 y | I | <2 | Relapsed to last line | 1. Trofosfamide | 60 | FluCy | CR | CR | 324 | Ongoing without event | Alive | No | — | No |
| 2. R-DHAP → ofatumumab + ICE → BEAM → HSCT with CR for ∼2 y | 2. Ofatumumab + gemcitabine + liposomal doxorubicin + vinorelbine | ||||||||||||||||
| 5 | 68 | F | 1. R-CHOP with CR for ∼1.5 y | I | <2 | Relapsed to last line | 1. Rituximab + bendamustine | 2 | FluCy | CR | PD at day 274 | 246 | New anticancer therapy other than HSCT | Died day 544, DLBCL | Grade 3 | 5 | Dysphagia grade 1 |
| 2. Rituximab + methotrexate + etoposide + ifosfamide with CR for ∼11 mo | |||||||||||||||||
| 6 | 64 | F | 1. R-CHOP + methotrexate with CR for ∼4 mo | IV | ≥2 | Relapsed to last line | 1. Rituximab + methotrexate + cytarabine | 71 | FluCy | CR | PD at day 196 | 165 | Withdrew consent | Lost to follow-up | No | — | No |
| 2. R-ICE with SD for ∼1 mo | |||||||||||||||||
| 3. Rituximab + methotrexate + cytarabine + methylprednisolone → busulfan + etoposide + cyclophosphamide (conditioning) → HSCT with CR for 4 mo | |||||||||||||||||
| 7 | 71 | F | 1. R-EPOCH with CR for ∼7 mo | III | ≥2 | Relapsed to last line | 1. Ifosfamide + carboplatin + etoposide | 24 | FluCy | CR | CR | 65 | Adequate assessment no longer available | Alive | Grade 2 | 12 | No |
| 2. R-GDP with PR for ∼3 mo | |||||||||||||||||
| Overall JULIET population5 | |||||||||||||||||
| 56 | 35.5% F | 1: 5% | I: 7% | <2 risk factors: 27.9% | Relapse: 45% | 92% | 56 | 93% (FluCy: 73%; bendamustine: 20%) | 40% CR | — | — | — | 90% OS rate at 12 mo in patientts with CR | 22% grade 3/4 | — | 12% grade 3/4 | |
| 64.5% M | 2: 44% | II: 17% | 12% PR | ||||||||||||||
| 3: 31% | III: 20% | ≥2 risk factors: 72.1% | Refractory: 55% | ||||||||||||||
| 4-6: 21% | IV: 56% |
All 7 patients had DLBCL except 1 patient with transformed follicular lymphoma. In JULIET, 79% had DLBCL and 19% had transformed follicular lymphoma.
—, not applicable; BEAM, carmustine, etoposide, cytarabine, melphalan; BOR, best overall response; chemo, chemotherapy; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; DOR, duration of response; F, female; FluCy, fludarabine plus cyclophosphamide; HSCT, hematopoietic stem-cell transplantation; ICE, ifosfamide, carboplatin, etoposide; IPI, International Prognostic Index; LD chemo, lymphodepleting chemotherapy; M, male; NT, neurotoxicity; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone; R-DHAP, rituximab plus dexamethasone, cytarabine, cisplatin; R-EPOCH, rituximab plus etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin; R-GDP, rituximab plus gemcitabine, dexamethasone, and cisplatin; SD, standard deviation; WBC, white blood cell.
Duration of bridging therapies is calculated from the first dose of bridging therapy to the last dose of bridging therapy. Dexamethasone was not included in the calculation of duration of bridging therapy.
DOR was measured from date of BOR until disease relapse or death.