Table 1.
Clinical trials with blinatumomab in R/R B-cell precursor ALL with published results
| Phase | ClinicalTrials.gov identifier (Acronym) | Title | N | Blinatumomab treatment | Baseline characteristics | Treatment exposure | References |
|---|---|---|---|---|---|---|---|
| R/R ALL, adults (Ph−) | |||||||
| II | NCT01209286 (MT103-206) | An open-label, multicenter, exploratory phase II study to evaluate the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | 36 | 5–30 μg/m2/day × 28 days | Median age, 32 years Prior transplant, 42% ≥2 salvage therapies, 19% Ph+, 6% Median blasts at screening, 77% |
Median treatment exposure, 55 d (range 1–150), with 4 patients completing 5 cycles of blinatumomab Median cumulative dose, 712 µg/m2 |
[25] |
| II | NCT01466179 (MT103-211) | An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE® antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | 189 | Cycle 1 (4 weeks): 9 μg/day × 7 days; 28 μg/day × 3 weeks Subsequent cycles: 28 μg/day |
Median age, 39 years Prior transplant, 34% ≥2 salvage therapies, 57% Median blasts at screening, 87% |
Median treatment exposure, 42 d (range 1–150) Median no. of completed treatment cycles, 1 (range 0–5) Median cumulative dose, 655 µg/m2 |
[26] |
| III | NCT02013167 (TOWER) | A phase 3, randomized, open label study investigating the efficacy of the BiTE® antibody blinatumomab versus standard of care chemotherapy in adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) (TOWER study) | 405 Blinatumomab, 271; SOC, 134 |
Cycle 1 (4 weeks): 9 μg/day × 7 days; 28 μg/day × 3 weeks Subsequent cycles: 28 μg/day |
Median age, 37 years Prior transplant, 35% ≥2 salvage therapies, 56% Median blasts at screening, 81% |
Median blinatumomab treatment exposure, 54 days (range 0–258) Median no. of cycles completed, 2 (range 0–9) Median cumulative dose, 1265 μg |
[13] |
| R/R ALL, adults (Ph+) | |||||||
| II | NCT02000427 (ALCANTARA) | A phase 2 single arm, multicenter trial to evaluate the efficacy of the BiTE® antibody blinatumomab in adult subjects with relapsed/refractory Philadelphia positive B-precursor acute lymphoblastic leukemia (ALCANTARA study) | 45 | Cycle 1 (4 weeks): 9 μg/day × 7 days; 28 μg/day × 3 weeks Subsequent cycles: 28 μg/day |
Median age, 55 years Prior transplant, 44% ≥2 salvage therapies, 42% Median blasts at screening, 80% |
Median treatment exposure 54 d (range 11–141) Median no. of cycles completed, 2 (range 1–5) Median cumulative dose, 1238 µg/m2 |
[22] |
| R/R ALL, pediatrics | |||||||
| I/II | NCT01471782 (MT103-205) | Clinical study with blinatumomab in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia | Phase I, 49 Phase II, 44 |
3.75–60 μg/m2/day × 28 days 5–15 μg/m2/day step dose |
Median age, 8 years Prior transplant, 57% ≥2 salvage therapies, 31% Cytogenetic or molecular aberrations, 52% Median blasts at baseline, 76%. |
Median treatment exposure was 29 d (range 2–159) Median no. of cycles completed was 1 (range 0–5) Median cumulative dose was 350 µg (range 16–4099) |
[23, 24] |
ALL acute lymphoblastic leukemia, BiTE® bispecific T-cell engager, Ph Philadelphia chromosome, R/R relapsed/refractory