This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Tafasitamab will be administered intravenously at protocol defined timepoints.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Time frame: Up to 52 weeks
Stable platelet response
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Time frame: After Day 56 up to Week 48
Stable hemoglobin response
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
Time frame: After Day 56 up to Week 48
Complete Response (CR)
Defined as platelet count ≥ 100 × 109/L at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Time frame: Week 24
CR (complete remission)
Defined as platelet count ≥ 100 × 109/L at Week 48 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Time frame: Week 48
Partial Response (PR)
Defined as platelet count ≥ 30 × 109/L and at least a 2-fold increase of baseline platelet count at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Time frame: Week 24
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RECRUITINGUsc Norris Comprehensive Cancer Center
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NOT_YET_RECRUITINGYale University School of Medicine
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NOT_YET_RECRUITINGGnp Research
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Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGSt Vincent'S Hospital Sydney
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RECRUITING...and 29 more locations
Duration of stable platelet response
Defined as time from start of stable platelet response to loss of platelet response (\< 50 × 109/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Time frame: Up to Week 48
Duration of CR
Defined as time from the start of CR to loss of CR (platelet count \< 100 × 109/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Time frame: Up to Week 48
Duration of response
Defined as time from the date of the first response (PR or CR) to the loss of response (platelet count \< 30 × 109/L or a less than a 2-fold increase of baseline platelet count), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
Time frame: Up to Week 48
CR
Defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 24 in the absence of rescue therapy in participants with primary wAIHA.
Time frame: Week 24
CR (Complete remission)
Defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 48 in the absence of rescue therapy in participants with primary wAIHA.
Time frame: Week 48
PR
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline at Week 24 in the absence of rescue therapy in participants with primary wAIHA.
Time frame: Week 24
Duration of stable hemoglobin response
Defined as time from start of stable hemoglobin response to loss of stable hemoglobin response (\< 10 g/dL or a \< 2 g/dL increase from baseline), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Time frame: Up to Week 48
Duration of CR
Defined as time from start of CR to loss of CR (hemoglobin \< 12 g/dL or abnormal hemolytic markers \[unconjugated bilirubin, LDH, haptoglobin, and reticulocytes\]), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Time frame: Up to Week 48
Duration of response
Defined as time from the date of the first response (PR or CR) to the loss of response (hemoglobin \< 10 g/dL), need for rescue therapy, or death, whichever occurs first in participants with primary wAIHA.
Time frame: Up to Week 48
Serum concentrations of tafasitamab
Serum concentrations of tafasitamab at each assessed timepoint.
Time frame: Up to Week 48
Change from baseline in serum antidrug antibody levels
Time frame: Up to Week 48