Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in Pediatric Refractory/Relapsed Acute Lymphoblastic Leukemia
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Procedures
2.3. Blinatumomab Dosage and Administration
2.4. Statistical Analysis
3. Results
3.1. Patients’ Characteristics
3.2. The Number of Blinatumomab Cycles and Treatment Modifications
3.3. Outcomes
3.4. Toxicity of Blinatumomab Therapy
3.5. T-Cell and B-Cell Kinetics
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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Features | |
---|---|
Age at initial diagnosis in years | |
Median (range) | 5.0 (8 months–10 years) |
Age at onset of blinatumomab | |
Median (range) | 8.0 (1–17 years) |
Sex (n (%)) | |
Boys | 8 (61.5%) |
Girls | 5 (38.5%) |
Genetic aberration | |
ETV6-RUNX1 | 2 |
KMT2A | 1 |
Hyperdiploidy | 3 |
Hypodiploidy | 1 |
No known genetic aberration | 6 |
Disease status prior blinatumomab therapy | |
Refractory disease | 1 |
1st relapse | 10 |
2nd relapse | 1 |
3rd relapse | 1 |
Time of relapse | |
Very early (<18 months from diagnosis) | 1 |
Early (>18 and <36 months from diagnosis) | 2 |
Late (>36 months from diagnosis) | 10 |
Leukemia load at onset of blinatumomab therapy (leukemic blasts in BM (%)) | |
>50 | 1 |
25–50 | 2 |
5–25 | 0 |
<5 | 10 |
Extramedullary manifestation before onset of blinatumomab (n) | |
CNS * (facial nerves paralysis/infiltration in MRI) | 1 |
Toxicity of Blinatumomab | Number of Patients (Total = 13) |
---|---|
All adverse events (AEs), any grade | 20 |
grade 3 CTCAE | 7 |
grade 4 CTCAE | 3 |
Severe adverse events (SAEs) | 4 |
AE leading to treatment interruption | 3 |
AE leading to treatment cessation | 1 |
Fatal AE | 0 |
Cytokine release syndrome grade 3 CTCAE | 1 |
Anemia | 8 |
Thrombocytopenia | 4 |
Neutropenia | 5 |
Hypotension | 1 |
Seizures | 2 |
Tremor | 2 |
Headache | 4 |
Fever | 5 |
Increase of AST/ALT grade 3 CTCAE grade 4 CTCAE | 4 1 |
Hypertension | 1 |
Legs pain | 2 |
Hypokalemia | 3 |
Hyperferritinemia | 4 |
Number N = 13 | MRD-FC Prior 1st Cycle | MRD-FC Post 1st Cycle | MRD-FC Post 2nd Cycle | Responder (R) vs. Nonresponder (NR) | Treatment Post Blinatumomab | Follow-Up Duration (Months) |
---|---|---|---|---|---|---|
1 | 32.7% | 0.36% | <0.01% | R | MUD HSCT | 47 |
2 | 0.1% | <0.01% | R | MSD HSCT | 40 | |
3 | 0.1% | <0.01% | R | MSD HSCT | 38 | |
4 * | 0.01% | <0.01% | - | R | MUD HSCT | 39 |
5 | 55% | 97% | NR | Palliative care | 1 DEAD | |
6 | 0.03% | <0.01% | <0.01% | R | MUD HSCT | 32 |
7 | 37% | 28% | NR | Clofarabine | 3 DEAD | |
8 | 0.03% | <0.01% | <0.01% | R | MSD HSCT | 26 |
9 | 0.2% | <0.01% | R | haploidentical HSCT | 23 | |
10 | 0.15% | <0.01% | <0.01% | R | haploidentical HSCT | 22 |
11 | 0.01% | <0.01% | <0.01% | R | MUD HSCT | 14 |
12 | 0.2% | <0.01% | R | MUD HSCT | 25 | |
13 | 0.15% | <0.01% | R | MUD HSCT | 2 |
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Pawinska-Wasikowska, K.; Wieczorek, A.; Balwierz, W.; Bukowska-Strakova, K.; Surman, M.; Skoczen, S. Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in Pediatric Refractory/Relapsed Acute Lymphoblastic Leukemia. Cancers 2022, 14, 458. https://doi.org/10.3390/cancers14020458
Pawinska-Wasikowska K, Wieczorek A, Balwierz W, Bukowska-Strakova K, Surman M, Skoczen S. Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in Pediatric Refractory/Relapsed Acute Lymphoblastic Leukemia. Cancers. 2022; 14(2):458. https://doi.org/10.3390/cancers14020458
Chicago/Turabian StylePawinska-Wasikowska, Katarzyna, Aleksandra Wieczorek, Walentyna Balwierz, Karolina Bukowska-Strakova, Marta Surman, and Szymon Skoczen. 2022. "Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in Pediatric Refractory/Relapsed Acute Lymphoblastic Leukemia" Cancers 14, no. 2: 458. https://doi.org/10.3390/cancers14020458