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THE PROGNOSIS FACTORS OF CAR-T THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY B-ALL
Author(s): ,
Yi Wang
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital ,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital ,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital ,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital ,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital ,Xi'An,China;Department of Hematology,S
,
Xingxing Hu
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Ding Zhang
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Qiuying Gao
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Xinhui Zhai
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Hui Wang
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Ying Gao
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Yudi Miao
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Ying Guo
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Weihua Zhang
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Xingli Ru
Affiliations:
Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Chine;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,Cina;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanxi Provincial People's Hospital,Xi'An,China;Department of Hematology,Shaanx
,
Xiang Li
Affiliations:
School of Medicine,Northwest University,Xi'An,Chine;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,Cina;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest Universi
Feng Guan
Affiliations:
School of Medicine,Northwest University,Xi'An,Chine;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,Cina;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest University,Xi'An,China;School of Medicine,Northwest Universi
(Abstract release date: 05/12/22) EHA Library. Hu X. 06/10/22; 357241; P378
Xingxing Hu
Xingxing Hu
Contributions
Abstract
Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P378

Type: Poster presentation

Session title: Acute lymphoblastic leukemia - Clinical

Background
CAR-T therapy showed good clinical efficacy on relapsed/refractory B-ALL (R/R B-ALL) patients. However, some latest studies revealed that most patients tend to relapse during long-term follow-up after CAR-T infusion. Few studies have examined the factors associated with the prognosis of R/R B-ALL patients.

Aims
The aim of the study is to investigate the factors associated with the long-term survival of R/R B-ALL patients after CAR-T therapy.

Methods
Thirty-eight R/R B-ALL patients were included in the study. Patients received CAR-T cells infusion from May 2015 to August 2018 in Shaanxi Provincial People's Hospital. Peripheral blood mononuclear cells were collected, and CD3+ cells were sorted. CAR-T cells were prepared by lentivirus. These cells were transfused 3 to 5 days after lymphocyte removal. Bone marrow smears, flow cytometry, and QT-PCR were used to assess the development of disease between 2 and 4 weeks after infusion. The endpoint of follow-up was the time of death or Feb 15, 2022. Cox regression models were used to analyse prognosis factors.

Results
The median age of the 38 patients was 25 years (6-59 years), including 21 males and 17 females. 26.3% (10/38) of patients had leukemic cells higher than 30% in their bone marrow smears. There were 34.21% (13/38) of patients with Ph(+), 34.21% (13/38) with extramedullary disease (EMD), 10.52% (4/38) with MLL-AF4 fusion gene (+), and 5.26% (2/38) had received HSCT prior to CAR-T therapy. Within 4 weeks of CAR-T cells infusion, 86.84% (33/38) of patients achieved MRD (-). 13 patients were disease-free by Feb 15, 2022. For all the 38 patients, the median OS and DFS were 19 months and 16.5 months. We found that a higher proportion of leukemic cells in bone marrow, MRD (+) after CAR-T infusion and the presence of the MLL-AF4 fusion gene could predict a worse prognosis. We found that sex, Ph (+), and HSCT after CAR-T infusion is not associated with the long-term survival of patients. Patients who had received maintenance therapy after CAR-T therapy showed better OS (49 months vs 9 months, P<0.001) and DFS (49 months vs 6 months, P<0.001) compared to those who received no maintenance therapy. In addition, we unexpectedly found that patients with EMD showed better OS (49 months vs 15 months, P=0.019) and DFS (49 months vs 12 months, P=0.045) than those without EMD.

Conclusion
R/R B-ALL patients could achieve long-term survival with CAR-T cell therapy. The proportion of leukemic cells in bone marrow, MRD(+), and the presence of the MLL-AF4 fusion gene could predict a worse prognosis of R/R B-ALL patients. We found that maintenance treatment after CAR-T therapy could significantly improve patients’ long-term survival and disease-free time, while HSCT showed no significant benefit to long-term prognosis.

Keyword(s): Acute lymphoblastic leukemia, CAR-T, Prognosis

Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P378

Type: Poster presentation

Session title: Acute lymphoblastic leukemia - Clinical

Background
CAR-T therapy showed good clinical efficacy on relapsed/refractory B-ALL (R/R B-ALL) patients. However, some latest studies revealed that most patients tend to relapse during long-term follow-up after CAR-T infusion. Few studies have examined the factors associated with the prognosis of R/R B-ALL patients.

Aims
The aim of the study is to investigate the factors associated with the long-term survival of R/R B-ALL patients after CAR-T therapy.

Methods
Thirty-eight R/R B-ALL patients were included in the study. Patients received CAR-T cells infusion from May 2015 to August 2018 in Shaanxi Provincial People's Hospital. Peripheral blood mononuclear cells were collected, and CD3+ cells were sorted. CAR-T cells were prepared by lentivirus. These cells were transfused 3 to 5 days after lymphocyte removal. Bone marrow smears, flow cytometry, and QT-PCR were used to assess the development of disease between 2 and 4 weeks after infusion. The endpoint of follow-up was the time of death or Feb 15, 2022. Cox regression models were used to analyse prognosis factors.

Results
The median age of the 38 patients was 25 years (6-59 years), including 21 males and 17 females. 26.3% (10/38) of patients had leukemic cells higher than 30% in their bone marrow smears. There were 34.21% (13/38) of patients with Ph(+), 34.21% (13/38) with extramedullary disease (EMD), 10.52% (4/38) with MLL-AF4 fusion gene (+), and 5.26% (2/38) had received HSCT prior to CAR-T therapy. Within 4 weeks of CAR-T cells infusion, 86.84% (33/38) of patients achieved MRD (-). 13 patients were disease-free by Feb 15, 2022. For all the 38 patients, the median OS and DFS were 19 months and 16.5 months. We found that a higher proportion of leukemic cells in bone marrow, MRD (+) after CAR-T infusion and the presence of the MLL-AF4 fusion gene could predict a worse prognosis. We found that sex, Ph (+), and HSCT after CAR-T infusion is not associated with the long-term survival of patients. Patients who had received maintenance therapy after CAR-T therapy showed better OS (49 months vs 9 months, P<0.001) and DFS (49 months vs 6 months, P<0.001) compared to those who received no maintenance therapy. In addition, we unexpectedly found that patients with EMD showed better OS (49 months vs 15 months, P=0.019) and DFS (49 months vs 12 months, P=0.045) than those without EMD.

Conclusion
R/R B-ALL patients could achieve long-term survival with CAR-T cell therapy. The proportion of leukemic cells in bone marrow, MRD(+), and the presence of the MLL-AF4 fusion gene could predict a worse prognosis of R/R B-ALL patients. We found that maintenance treatment after CAR-T therapy could significantly improve patients’ long-term survival and disease-free time, while HSCT showed no significant benefit to long-term prognosis.

Keyword(s): Acute lymphoblastic leukemia, CAR-T, Prognosis

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