Table 1

Demographics and responses of patients who received ibrutinib before CAR T-cell therapy

Subject UPNAge, y/sexPrevious therapiesCLL tumor characteristicsIbrutinib status during T-cell collectionCLL involvement at CTL019 infusionResponse to CTL019
18 61/male Fludarabine/cyclophosphamide/rituximab × 6 cycles
Bendamustine/rituximab × 1 cycle
Oxaliplatin/fludarabine/cytarabine/rituximab × 2 cycles
Selinexor × 1 cycle Ibrutinib × 12 mo 
trisomy 12; del12q14; del11q; del17p Discontinued 2 mo before T-cell collection Cytopenias; BM 20% involved with CLL; bulky diffuse adenopathy Marked PR; cytopenias resolved at 2 mo; BM minimally involved; >50% decrease in adenopathy; relapsed with CD19-negative disease 
29 68/male Rituximab/fludarabine × 6 cycles
Ofatumumab × 2 cycles
Bendamustine/ofatumumab × 1 cycle
Ibrutinib × 15 mo 
13qdel; trisomy 21; 17pdel Discontinued 11 d before T-cell collection Blood involved; BM 25% involved with CLL; diffuse adenopathy PR: cleared blood and BM at day 28; persistent adenopathy 
47 57/male Fludarabine/cyclophosphamide/rituximab × 3 cycles
Bendamustine × 1 cycle
Ibrutinib × 16 mo 
p53del Ongoing at T-cell collection*; discontinued 7 d before CTL019 treatment, per protocol Normal ALC; BM 70% involved with CLL; diffuse adenopathy CR: cleared blood and BM at day 28; no adenopathy 
Subject UPNAge, y/sexPrevious therapiesCLL tumor characteristicsIbrutinib status during T-cell collectionCLL involvement at CTL019 infusionResponse to CTL019
18 61/male Fludarabine/cyclophosphamide/rituximab × 6 cycles
Bendamustine/rituximab × 1 cycle
Oxaliplatin/fludarabine/cytarabine/rituximab × 2 cycles
Selinexor × 1 cycle Ibrutinib × 12 mo 
trisomy 12; del12q14; del11q; del17p Discontinued 2 mo before T-cell collection Cytopenias; BM 20% involved with CLL; bulky diffuse adenopathy Marked PR; cytopenias resolved at 2 mo; BM minimally involved; >50% decrease in adenopathy; relapsed with CD19-negative disease 
29 68/male Rituximab/fludarabine × 6 cycles
Ofatumumab × 2 cycles
Bendamustine/ofatumumab × 1 cycle
Ibrutinib × 15 mo 
13qdel; trisomy 21; 17pdel Discontinued 11 d before T-cell collection Blood involved; BM 25% involved with CLL; diffuse adenopathy PR: cleared blood and BM at day 28; persistent adenopathy 
47 57/male Fludarabine/cyclophosphamide/rituximab × 3 cycles
Bendamustine × 1 cycle
Ibrutinib × 16 mo 
p53del Ongoing at T-cell collection*; discontinued 7 d before CTL019 treatment, per protocol Normal ALC; BM 70% involved with CLL; diffuse adenopathy CR: cleared blood and BM at day 28; no adenopathy 

ALC, absolute lymphocyte count; BM, bone marrow; PR, partial response; UPN, unique patient number.

*

Modified CTL019 manufacturing process.

Absolute lymphocyte count.

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