Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
3. Results
3.1. Patient Characteristics
3.2. Treatment
3.3. Response
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Baseline Characteristics | Patients: n (%) |
---|---|
Age in years, median (range) | 20 (6–21) |
Sex | |
Female | 5 (28) |
Male | 13 (72) |
Race | |
Asian | 5 (28) |
Black | 1 (5) |
Hispanic | 5 (28) |
White | 7 (39) |
Diagnosis | |
B-cell ALL | 5 (28) |
T-cell ALL | 7 (39) |
T-cell LBL | 6 (33) |
Prior Regimens | |
0 | 4 (22) |
1 | 6 (33) |
>3 | 8 (44) |
Previous Transplantation | |
Yes | 5 (28) |
No | 13 (72) |
Patient Number | Diagnosis | Age/Sex | Cytogenetics | NGS and PCR Mutation Findings | Number of Prior Therapies | Prior Therapy | Concurrent Chemotherapy | Dosing Schedule | Cycles | Response | Toxicity |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | T-cell LBL | 12/M | Negative | Negative | 1 | AALL0434 | HyperCVAD, Decitabine | 100 mg/day (concurrent Posaconazole) | 2 | NR | Thrombocytopenia |
2 | T-cell LBL | 20/M | Unknown | Unknown | 4 | AALL1231; NECTAR protocol; Clofarabine; Cytarabine/Mitoxantrone | Decitabine | 400 mg/day | 1 | CR | Febrile neutropenia, thrombocytopenia, coagulopathy |
3 | T-cell LBL | 20/M | 2 extra copies of PDGFRB | Negative | 1 | HyperCVAD | HyperCVAD, nelarabine | 400 mg/day | 7 | CR | Sepsis, pancreatitis |
4 | T-cell LBL | 20/F | Negative | STAT5A, SH2B3, ASXL2, RUNX1, PHF6 | 0 | None | HyperCVAD, nelarabine, pegASP | 400 mg/day | 4 | CR | Thrombocytopenia, neutropenia |
5 | T-cell LBL | 21/M | Negative | Negative | 0 | None | HyperCVAD, nelarabine | 400 mg/day | 3 | CR | Thrombocytopenia |
6 | T-cell LBL | 21/F | Negative | NOTCH1, TP53, BCORL1 | 1 | HyperCVAD | Fludarabine, cytarabine, idarubicin, pegASP | 400 mg/day | 2 | CR | Febrile neutropenia, sepsis, myelosuppression |
7 | T-cell ALL | 21/M | TP53 deletion | NOTCH1, KDM6A, CREBBP | 5 | HyperCVAD; Nelarabine; MOAD; HSCT; MOAD | Nelarabine, etoposide, cyclophosphamide, decitabine | 400 mg/day | 1 | NR | Pneumonia, sepsis, thrombocytopenia, hyperbilirubinemia |
8 | T-cell ALL | 19/M | Negative | NOTCH1, IL7F | 0 | None | HyperCVAD | 400 mg/day | 13 | CR | Thrombocytopenia, sepsis, hyperbilirubinemia |
9 | T-cell ALL | 17/M | iAMP21, trisomy 8 | NOTCH1, STAT5B | 1 | AALL0434 | HyperCVAD | 200 mg/day (concurrent voriconazole) | 1 | CRi | Febrile neutropenia, thrombocytopenia |
10 | ETP T-cell ALL | 19/M | Negative | TCRG rearrangement | 1 | AALL0434; cyclophosphamide, cytarabine | Fludarabine, cytarabine, gemtuzumab, methotrexate | 100 mg/day (concurrent voriconazole) | 1.5 | CR | Thrombocytopenia, neutropenia |
11 | T-cell ALL | 18/M | t(4;6) | IL7R, NOTCH1, SF3A1, TCRB/G rearrangement | 3 | AALL0434; CALBG; HyperCVAD | HyperCVAD | 400 mg/day | 1 | NR | Thrombocytopenia, neutropenia |
12 | T-cell ALL | 21/M | Negative | NOTCH1, KDM6A | 0 | None | HyperCVAD, nelarabine, pegASP | 400 mg/day | 7 | CR | Febrile neutropenia, thrombocytopenia |
13 | T-cell ALL | 22/M | Negative | SUZ12, NOTCH1, FBXW7, KRAS, WT1, Deletion CDKN2A and P16 | 1 | HyperCVAD | Nelarabine, pegASP, Gemtuzumab | 100 mg/day | 2 | CR | none |
14 | B-cell ALL | 21/F | One copy loss of FGFR1, one copy gain of CRLF2 | PAX5, STAG2 | 5 | ALL1131; HyperCVAD, rituximab, inotuzumab, blinatumomab; HSCT; blinatumomab, MTX, AraC; Kymriah | CVD | 400 mg/day | 2 | CRi | Febrile neutropenia, thrombocytopenia |
15 | B-cell ALL | 18/M | ETV6/RUNX1 rearrangement | Negative | 6 | ALLR3; HSCT; HyperCVAD; Decitabine; Sleeping Beauty CAR-T; Kymriah | CVD | 100 mg/day (concurrent voriconazole) | 1 | NR | Thrombocytopenia, neutropenia |
16 | B-cell ALL | 11/M | ETV6/RUNX1 fusion | ASXL2, ETV6, TP53 | 6 | AALL0932; KITE; Kymriah; CD19/CD22 CAR; HSCT transplant; AALL0434 | CVD | 340 mg/day (360 mg/m2) | 1 | NR | Myelosuppression, hyperbilirubinemia |
17 | B-cell ALL | 20/F | One copy loss of ABL1, ABL2, PDGFR, CRLF2; one copy gain of JAK2, ETV6, RUNX1, amplification of KMT2A | NF1, TP53, WT1 | 3 | HyperCVAD, inotuzumab; fludarabine, cytarabine; CD22 CAR | HyperCVAD, rituximab | 100 mg (concurrent voriconazole) | 1 | NR | Thrombocytopenia |
18 | B-cell ALL | 6/F | Negative | ASXL2, BCORL1, CREBBP, DNMT3A, NF1, PAX5, FLT3, SF1, KMT2A | 8 | ALLR3 + Bortezomib; Kymriah; Blinatumomab; AALL1621; AALL1131; Nivolumab; vincristine/daunorubicin/MTX | CVD | 70 mg/day (concurrent voriconazole) | 1 | NR | Thrombocytopenia, sepsis, hyperbilirubinemia |
Adverse Event | ≥Grade 3 N (%) | Grade 3 | Grade 4 |
---|---|---|---|
Thrombocytopenia | 16 (89) | 0 | 16 |
Neutropenia | 10 (53) | 0 | 9 |
Elevated bilirubin | 4 (22) | 4 | 0 |
Sepsis | 5 (28) | 4 | 1 |
Febrile neutropenia | 5 (28) | 2 | 3 |
Elevated AST/ALT | 1 (5) | 1 | 0 |
Pneumonia | 1 (5) | 0 | 1 |
Coagulopathy | 1 (5) | 0 | 1 |
Mucosal infection | 1 (5) | 1 | 0 |
Response | CR/CRi # (%) | NR |
---|---|---|
Overall | 11 (61) | 7 (39) |
Overall R/R disease | 7 (50) | 7 (50) |
Overall T-cell disease (ALL/LBL) | 10 (77) | 3 (23) |
R/R T-cell ALL/LBL | 6 (75%) | 2 (25) |
Overall T-cell LBL | 5 (83) | 1 (17) |
R/R T-cell LBL | 3 (75) | 1 (25) |
Upfront T-cell LBL | 2 (100) | 0 |
Overall T-cell ALL | 5 (71) | 2 (29) |
R/R T-cell ALL | 3 (75) | 1 (25) |
Upfront T-cell ALL | 2 (100) | 0 |
Overall B-cell ALL | 1 (20) | 4 (80) |
R/R B-cell ALL | 1 (20) | 4 (80) |
Upfront B-cell ALL | - | - |
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Gibson, A.; Trabal, A.; McCall, D.; Khazal, S.; Toepfer, L.; Bell, D.H.; Roth, M.; Mahadeo, K.M.; Nunez, C.; Short, N.J.; et al. Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Cancers 2022, 14, 150. https://doi.org/10.3390/cancers14010150
Gibson A, Trabal A, McCall D, Khazal S, Toepfer L, Bell DH, Roth M, Mahadeo KM, Nunez C, Short NJ, et al. Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Cancers. 2022; 14(1):150. https://doi.org/10.3390/cancers14010150
Chicago/Turabian StyleGibson, Amber, Adriana Trabal, David McCall, Sajad Khazal, Laurie Toepfer, Donna H. Bell, Michael Roth, Kris M. Mahadeo, Cesar Nunez, Nicholas J. Short, and et al. 2022. "Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma" Cancers 14, no. 1: 150. https://doi.org/10.3390/cancers14010150
APA StyleGibson, A., Trabal, A., McCall, D., Khazal, S., Toepfer, L., Bell, D. H., Roth, M., Mahadeo, K. M., Nunez, C., Short, N. J., DiNardo, C., Konopleva, M., Issa, G. C., Ravandi, F., Jain, N., Borthakur, G., Kantarjian, H. M., Jabbour, E., & Cuglievan, B. (2022). Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Cancers, 14(1), 150. https://doi.org/10.3390/cancers14010150