Patient, tumor, and TDL product characteristics and clinical outcomes.
| Patient characteristics . | Tumor and TDL product characteristics . | Clinical Outcomes . | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. . | Primary diagnosis . | Donor . | Conditioning (TCD) . | TTP post-AlloSCT, mo . | Relapse duration, mo . | Maximum prior GVHD . | Post-Allo ChemoRx . | Post-Allo donor cells . | Tumor . | TDL . | Toxicity . | Response (duration) . | Survival, mo* . | ||||||
| Acute skin/liver/GI . | Chronic grade . | Tumor harvest . | T cell, % . | Culture, d . | T cell, % . | Expansion: T, fold . | Donor, % . | Cell dose, 106/kg . | |||||||||||
| 1 | DLBCL/t-FL | MRD | RIC (none) | 0 | 10 | 2/0/2 | None | 3 | 1 | Flank | 5 | 28 | 98 | 54 | 100 | 5.8 | PD | 1.1 | |
| 2 | Lymphoblastic | UCB (2) | MA (none) | 10 | 8 | 2/0/0 | Mild | 2† | 0 | Neck | 0.5 | 36‡ | 82 | 60 | 92 | 14.5 | PD | 1.4 | |
| 3 | HL (1° Ref) | MUD | MA (R-ATG) | 6 | 16 | 0/0/0 | None | 1 | 1 | Axilla | 56 | 12 | 91 | 65 | 100 | 10.6 | NE | 2.1 | |
| 4 | HL (Rel) | MRD | RIC (none) | 15 | 54 | 0/0/0 | Moderate | 5 | 2 | Axilla | 63 | 9 | 88 | 22 | 100 | 9.3 | SD (5 mo) | 33.9 | |
| 5 | HL (1° Ref) | MUD | RIC (alemtuzumab) | 3 | 16 | 0/0/0 | None | 1 | 2 | Groin | 71 | 7 | 93 | 39 | 100 | 100 | Grade 4 pneumonitis‖ | NE/SD (1 mo) | 10.7 |
| 6 | HL (Rel) | MRD | MA (post-SCT Cy) | 3 | 26 | 0/0/0 | Mild | 1 | 0 | Axilla§ | 44 | 12 | 95 | 91 | 100 | 26.3 | Grade 2 pain | SD (3M) PET response | 6.4 |
| 7 | P53+ CLL | MUD | RIC (alemtuzumab) | 13 | 13 | 0/0/0 | Mild | 2 | 3 | Axilla | 8 | 8 | 97 | 144 | 99 | 98.6 | SD (2 mo) | 16.4 | |
| 8 | HL (Rel) | MRD | RIC (none) | 7 | 64 | 2/0/0 | Mild | 2 | 1 | Axilla | 54 | 12 | 96 | 30 | 100 | 91.2 | Grade 2 cytokine release | SD (4 mo) PET response | 9.5 |
| Median | 6 | 16 | 49 | 12 | 94 | 57 | 100 | 20.4 | 8.0 | ||||||||||
| Patient characteristics . | Tumor and TDL product characteristics . | Clinical Outcomes . | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. . | Primary diagnosis . | Donor . | Conditioning (TCD) . | TTP post-AlloSCT, mo . | Relapse duration, mo . | Maximum prior GVHD . | Post-Allo ChemoRx . | Post-Allo donor cells . | Tumor . | TDL . | Toxicity . | Response (duration) . | Survival, mo* . | ||||||
| Acute skin/liver/GI . | Chronic grade . | Tumor harvest . | T cell, % . | Culture, d . | T cell, % . | Expansion: T, fold . | Donor, % . | Cell dose, 106/kg . | |||||||||||
| 1 | DLBCL/t-FL | MRD | RIC (none) | 0 | 10 | 2/0/2 | None | 3 | 1 | Flank | 5 | 28 | 98 | 54 | 100 | 5.8 | PD | 1.1 | |
| 2 | Lymphoblastic | UCB (2) | MA (none) | 10 | 8 | 2/0/0 | Mild | 2† | 0 | Neck | 0.5 | 36‡ | 82 | 60 | 92 | 14.5 | PD | 1.4 | |
| 3 | HL (1° Ref) | MUD | MA (R-ATG) | 6 | 16 | 0/0/0 | None | 1 | 1 | Axilla | 56 | 12 | 91 | 65 | 100 | 10.6 | NE | 2.1 | |
| 4 | HL (Rel) | MRD | RIC (none) | 15 | 54 | 0/0/0 | Moderate | 5 | 2 | Axilla | 63 | 9 | 88 | 22 | 100 | 9.3 | SD (5 mo) | 33.9 | |
| 5 | HL (1° Ref) | MUD | RIC (alemtuzumab) | 3 | 16 | 0/0/0 | None | 1 | 2 | Groin | 71 | 7 | 93 | 39 | 100 | 100 | Grade 4 pneumonitis‖ | NE/SD (1 mo) | 10.7 |
| 6 | HL (Rel) | MRD | MA (post-SCT Cy) | 3 | 26 | 0/0/0 | Mild | 1 | 0 | Axilla§ | 44 | 12 | 95 | 91 | 100 | 26.3 | Grade 2 pain | SD (3M) PET response | 6.4 |
| 7 | P53+ CLL | MUD | RIC (alemtuzumab) | 13 | 13 | 0/0/0 | Mild | 2 | 3 | Axilla | 8 | 8 | 97 | 144 | 99 | 98.6 | SD (2 mo) | 16.4 | |
| 8 | HL (Rel) | MRD | RIC (none) | 7 | 64 | 2/0/0 | Mild | 2 | 1 | Axilla | 54 | 12 | 96 | 30 | 100 | 91.2 | Grade 2 cytokine release | SD (4 mo) PET response | 9.5 |
| Median | 6 | 16 | 49 | 12 | 94 | 57 | 100 | 20.4 | 8.0 | ||||||||||
Acute indicates acute GVHD stage per Keystone Consensus Criteria; chronic, chronic GVHD grade per IBMTR Criteria (then in we); CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; GI, gastrointestinal; HL, Hodgkin lymphoma (1° Ref, primary refractory; Rel, relapsed); MA, myeloablative; MRD, matched, related (sibling) donor; MUD, matched unrelated donor; NE, not evaluated; PD, progressive disease; PET response, partial response by positron emission tomography; PR, partial response; RIC, reduced-intensity conditioning; SD, stable disease; t-FL, transformed follicular lymphoma; TDL, tumor-derived donor lymphocyte; TTP, time to progression; and UCB, unrelated cord blood.
Post-Allo ChemoRx indicates number of relapse regimens received since AlloSCT; post-Allo donor cells, number of prior donor cell product infusions since AlloSCT; R-ATG post-SCT Cy, high-dose cyclophosphamide on days +3 and +4; and TCD, in vivo T-cell depletion for GVHD prophylaxis.
Acute GVHD staged per Keystone Consensus Criteria; Chronic GVHD Grade according in IBMTR Criteria, then in use.
Survival censored July 21, 2011. Bold values indicate deceased; italicized values indicate last contact.
PN2 received one cycle of cyclophosphamide, vincristine, doxorubicin and dexamethasone (Hyper-CVAD) after harvest, TDL infusion on day 19.
PN2 TDL product required extension of culture beyond the expansion target in order to meet criteria for residual tumor contamination.
PN6 required a second tumor harvest; the initial excision yielded a wholly sclerotic specimen.
PN5 presented to his local emergency room 22 days after TDL infusion with fever and shortness of breath. Computerized tomography (CT, pulmonary embolism-protocol) demonstrated stable tumor with new perinodular infiltrates. He refused bronchoscopy and was treated with broad-spectrum antimicrobials without improvement. He consented and underwent bronchoscopy with bronchoalveolar lavage 1 week later, and required intubation for the procedure. Microbiologic stains and cultures and cytopathologic examination were nondiagnostic. He was treated with steroids with prompt resolution of hypoxia and infiltrates, was extubated on the third day after the procedure, and was discharged 4 days later. Hypoxia and infiltrates recurred during rapid steroid taper and again resolved with increased oral steroid dose. Symptoms flared again with taper; he was treated with gemcitabine, vinorelbine, and liposomal doxorubicin with resolution of infiltrates and complete remission of HL.