Hematopoietic recovery and immune reconstitution after axicabtagene ciloleucel in patients with large B-cell lymphoma
Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene cilo...
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| Published in | Haematologica (Roma) Vol. 106; no. 10; pp. 2667 - 2672 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Italy
Fondazione Ferrata Storti
01.10.2021
Ferrata Storti Foundation |
| Subjects | |
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| Abstract | Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel at our institution on two clinical trials, ZUMA-1 (clinicaltrials gov. Identifier: NCT02348216) and ZUMA-9 (clinicaltrials gov. Identifier: NCT03153462). Complete blood counts, lymphocyte subsets, and immunoglobulin levels were measured serially until month 24 or progression. Fifteen (48%) patients had grade 3-4 cytopenia, including anemia (five, 16%), neutropenia (nine, 29%), or thrombocytopenia (13, 42%) at day 30. Cytopenia at day 30 was not significantly associated with later diagnosis of myelodysplasia. Among patients with ongoing remission, grade 3-4 cytopenia was observed in one of nine (11%) at 2 years. While peripheral CD8+ T cells recovered early, CD4+ T-cell recovery was delayed with a count of <200/mL in three of nine (33%) patients at 1 year and two of seven (29%) at 2 years. Immunoglobulin G levels normalized in five of nine (56%) patients at 2 years. Thirteen (42%) patients developed grade 3-4 infectious complications, including herpes zoster and Pneumocystis jiroveci pneumonia. These results suggest the need for prolonged monitoring and prophylaxis against opportunistic infections in these patients, to improve the longterm safety of axicabtagene ciloleucel therapy. |
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| AbstractList | Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel at our institution on two clinical trials, ZUMA-1 (clinicaltrials gov. Identifier: NCT02348216) and ZUMA-9 (clinicaltrials gov. Identifier: NCT03153462). Complete blood counts, lymphocyte subsets, and immunoglobulin levels were measured serially until month 24 or progression. Fifteen (48%) patients had grade 3-4 cytopenia, including anemia (five, 16%), neutropenia (nine, 29%), or thrombocytopenia (13, 42%) at day 30. Cytopenia at day 30 was not significantly associated with later diagnosis of myelodysplasia. Among patients with ongoing remission, grade 3-4 cytopenia was observed in one of nine (11%) at 2 years. While peripheral CD8
+
T cells recovered early, CD4
+
T-cell recovery was delayed with a count of <200/mL in three of nine (33%) patients at 1 year and two of seven (29%) at 2 years. Immunoglobulin G levels normalized in five of nine (56%) patients at 2 years. Thirteen (42%) patients developed grade 3-4 infectious complications, including herpes zoster and
Pneumocystis jiroveci
pneumonia. These results suggest the need for prolonged monitoring and prophylaxis against opportunistic infections in these patients, to improve the longterm safety of axicabtagene ciloleucel therapy. Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel at our institution on two clinical trials, ZUMA-1 (clinicaltrials gov. Identifier: NCT02348216) and ZUMA-9 (clinicaltrials gov. Identifier: NCT03153462). Complete blood counts, lymphocyte subsets, and immunoglobulin levels were measured serially until month 24 or progression. Fifteen (48%) patients had grade 3-4 cytopenia, including anemia (five, 16%), neutropenia (nine, 29%), or thrombocytopenia (13, 42%) at day 30. Cytopenia at day 30 was not significantly associated with later diagnosis of myelodysplasia. Among patients with ongoing remission, grade 3-4 cytopenia was observed in one of nine (11%) at 2 years. While peripheral CD8+ T cells recovered early, CD4+ T-cell recovery was delayed with a count of <200/mL in three of nine (33%) patients at 1 year and two of seven (29%) at 2 years. Immunoglobulin G levels normalized in five of nine (56%) patients at 2 years. Thirteen (42%) patients developed grade 3-4 infectious complications, including herpes zoster and Pneumocystis jiroveci pneumonia. These results suggest the need for prolonged monitoring and prophylaxis against opportunistic infections in these patients, to improve the longterm safety of axicabtagene ciloleucel therapy.Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel at our institution on two clinical trials, ZUMA-1 (clinicaltrials gov. Identifier: NCT02348216) and ZUMA-9 (clinicaltrials gov. Identifier: NCT03153462). Complete blood counts, lymphocyte subsets, and immunoglobulin levels were measured serially until month 24 or progression. Fifteen (48%) patients had grade 3-4 cytopenia, including anemia (five, 16%), neutropenia (nine, 29%), or thrombocytopenia (13, 42%) at day 30. Cytopenia at day 30 was not significantly associated with later diagnosis of myelodysplasia. Among patients with ongoing remission, grade 3-4 cytopenia was observed in one of nine (11%) at 2 years. While peripheral CD8+ T cells recovered early, CD4+ T-cell recovery was delayed with a count of <200/mL in three of nine (33%) patients at 1 year and two of seven (29%) at 2 years. Immunoglobulin G levels normalized in five of nine (56%) patients at 2 years. Thirteen (42%) patients developed grade 3-4 infectious complications, including herpes zoster and Pneumocystis jiroveci pneumonia. These results suggest the need for prolonged monitoring and prophylaxis against opportunistic infections in these patients, to improve the longterm safety of axicabtagene ciloleucel therapy. Chimeric antigen receptor (CAR) T-cell therapy targeting CD19 may be associated with long-term adverse effects such as cytopenia and immune deficiency. In order to characterize these late events, we analyzed 31 patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel at our institution on two clinical trials, ZUMA-1 (clinicaltrials gov. Identifier: NCT02348216) and ZUMA-9 (clinicaltrials gov. Identifier: NCT03153462). Complete blood counts, lymphocyte subsets, and immunoglobulin levels were measured serially until month 24 or progression. Fifteen (48%) patients had grade 3-4 cytopenia, including anemia (five, 16%), neutropenia (nine, 29%), or thrombocytopenia (13, 42%) at day 30. Cytopenia at day 30 was not significantly associated with later diagnosis of myelodysplasia. Among patients with ongoing remission, grade 3-4 cytopenia was observed in one of nine (11%) at 2 years. While peripheral CD8+ T cells recovered early, CD4+ T-cell recovery was delayed with a count of <200/mL in three of nine (33%) patients at 1 year and two of seven (29%) at 2 years. Immunoglobulin G levels normalized in five of nine (56%) patients at 2 years. Thirteen (42%) patients developed grade 3-4 infectious complications, including herpes zoster and Pneumocystis jiroveci pneumonia. These results suggest the need for prolonged monitoring and prophylaxis against opportunistic infections in these patients, to improve the longterm safety of axicabtagene ciloleucel therapy. |
| Author | Fredrick B. Hagemeister Loretta J. Nastoupil Paolo Strati Victor Eduardo Mulanovich Partow Kebriaei Sara Arafat Nathan H. Fowler Felipe Samaniego Sairah Ahmed Luis E. Fayad Sandra Horowitz Ella Ariza Heredia Jason Westin Swapna Johncy Ankur Varma Hun J. Lee Yiming Chen Sattva S. Neelapu Sherry Adkins |
| AuthorAffiliation | 2 Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center , Houston, TX 4 Division of Hematology, Oncology and Cellular Therapy, Rush University , Chicago, IL, USA 3 Department of Infectious Disease, The University of Texas MD Anderson Cancer Center , Houston, TX 1 Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center , Houston, TX |
| AuthorAffiliation_xml | – name: 1 Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center , Houston, TX – name: 2 Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center , Houston, TX – name: 3 Department of Infectious Disease, The University of Texas MD Anderson Cancer Center , Houston, TX – name: 4 Division of Hematology, Oncology and Cellular Therapy, Rush University , Chicago, IL, USA |
| Author_xml | – sequence: 1 givenname: Paolo surname: Strati fullname: Strati, Paolo organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 2 givenname: Ankur surname: Varma fullname: Varma, Ankur organization: Dept. of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 3 givenname: Sherry surname: Adkins fullname: Adkins, Sherry organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 4 givenname: Loretta J surname: Nastoupil fullname: Nastoupil, Loretta J organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 5 givenname: Jason surname: Westin fullname: Westin, Jason organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 6 givenname: Fredrick B surname: Hagemeister fullname: Hagemeister, Fredrick B organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 7 givenname: Nathan H surname: Fowler fullname: Fowler, Nathan H organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 8 givenname: Hun J surname: Lee fullname: Lee, Hun J organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 9 givenname: Luis E surname: Fayad fullname: Fayad, Luis E organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 10 givenname: Felipe surname: Samaniego fullname: Samaniego, Felipe organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 11 givenname: Sairah surname: Ahmed fullname: Ahmed, Sairah organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 12 givenname: Yiming surname: Chen fullname: Chen, Yiming organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 13 givenname: Sandra surname: Horowitz fullname: Horowitz, Sandra organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 14 givenname: Sara surname: Arafat fullname: Arafat, Sara organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 15 givenname: Swapna surname: Johncy fullname: Johncy, Swapna organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 16 givenname: Partow surname: Kebriaei fullname: Kebriaei, Partow organization: Dept. of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 17 givenname: Victor Eduardo surname: Mulanovich fullname: Mulanovich, Victor Eduardo organization: Department of Infectious Disease, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 18 givenname: Ella surname: Ariza Heredia fullname: Ariza Heredia, Ella organization: Department of Infectious Disease, The University of Texas MD Anderson Cancer Center, Houston, USA – sequence: 19 givenname: Sattva S surname: Neelapu fullname: Neelapu, Sattva S organization: Dept. of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32732355$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1200/JCO.2015.64.5929 10.1200/JCO.1995.13.10.2547 10.1093/cid/ciy152 10.1038/s41409-019-0487-3 10.1200/JCO.1999.17.10.3128 10.1056/NEJMoa1804980 10.1200/JCO.2006.09.2403 10.1056/NEJMoa1708566 10.1182/blood-2017-07-793760 10.1007/s11912-019-0789-z 10.1016/j.bbmt.2018.12.758 10.1016/S1470-2045(18)30864-7 10.1056/NEJMoa1707447 10.1182/blood-2008-02-140582 10.1182/blood-2016-04-703751 10.1016/j.bbmt.2007.12.497 10.1016/j.bbmt.2018.05.007 10.1056/NEJMoa1817226 10.1016/j.bbmt.2019.08.003 10.1038/nrclinonc.2017.148 10.1182/blood-2014-05-552729 10.1200/JCO.19.03279 10.1002/cncr.28318 10.1046/j.1525-1497.1998.00031.x 10.1182/blood-2019-127508 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 PS designed the study, analyzed data, and wrote the paper; LN, JW, FH, NF, HJL, LEF, FS, SA, PK, VEM and EAH provided clinical care to patients and coauthored the paper; YC, SH, SA, AV, SA, and SJ collected clinical data and co-authored the paper; SN designed the study, analyzed the data, provided clinical care to patients, and wrote the paper. Contributions SSN reports honoraria and research support from Kite, a Gilead Company, Merck, Celgene, Allogene, and Unum Therapeutics; research support from Bristol-Myers Squibb, Poseida, Cellectis, Karus, and Acerta Pharma; and honoraria from Novartis, Pfizer, Precision Biosciences, Cell Medica, Calibr, Incyte, and Legend Biotech. FS reports honoraria from Celgene. LN reports honoraria from Celgene, Genentech, Gilead, Janssen, Juno, Novartis, Spectrum, TG Therapeutics and research support from Celgene, Genentech, Janssen, Karus Therapeutics, and Merck. NF reports honoraria from Celgene, Gilead Sciences, Pharmacyclics, Roche Pharma AG, research support from Celgene, Gilead Sciences, Pharmacyclics, and Roche Pharma AG. Disclosure |
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| SubjectTerms | Antigens, CD19 Biological Products Humans Immune Reconstitution Immunotherapy, Adoptive Lymphoma, Large B-Cell, Diffuse - drug therapy Neutropenia |
| Title | Hematopoietic recovery and immune reconstitution after axicabtagene ciloleucel in patients with large B-cell lymphoma |
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