Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04827745
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2021-03-25
Brief Title:
Blinatumomab for Treatment of RR or MRD-positive CD19-Positive MPAL
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Multicenter Phase II Study of Blinatumomab for Treatment of Adult Patients With Morphologic RelapsedRefractory or Measurable Residual Disease MRD CD19-Positive Mixed Phenotype Acute Leukemia MPAL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study to find out if a drug called blinatumomab is effective for treating patients with relapsed or refractory RR or measurable residual disease MRD CD19-positive mixed phenotypic acute leukemia MPAL Measurable Residual Disease MRD means that there are a small number of cancer cells remaining after treatment
Detailed Description:
This is a multicenter non-randomized open-label phase II study evaluating the efficacy of blinatumomab to achieve the following objectives
1 The best morphologic response after the first two cycles of therapy in subjects with morphologic RR CD19-positive MPAL
2 MRD-negativity in subjects with CD19-positive MPAL in CR or CRh or CRi or CRp after receiving at least one chemotherapy block of standard ALL or AML treatment with MRD-positivity at a level of 01 using an assay with a minimum sensitivity of 001
The trial consists two groups Group A and B and three phases induction consolidation and maintenance of therapy Subject will receive study drug blinatumomab by continuous IV infusion CIV Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 143 days treatment-free interval for induction 283 days treatment-free interval for consolidation and 563 days treatment-free interval for maintenance
Blinatumomab is approved by Food and Drug Administration FDA and European Medicines Agency EMA for use in people with another type of acute leukemia called acute lymphoblastic leukemia ALL but not MPAL
1 The best morphologic response after the first two cycles of therapy in subjects with morphologic RR CD19-positive MPAL
2 MRD-negativity in subjects with CD19-positive MPAL in CR or CRh or CRi or CRp after receiving at least one chemotherapy block of standard ALL or AML treatment with MRD-positivity at a level of 01 using an assay with a minimum sensitivity of 001
The trial consists two groups Group A and B and three phases induction consolidation and maintenance of therapy Subject will receive study drug blinatumomab by continuous IV infusion CIV Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 143 days treatment-free interval for induction 283 days treatment-free interval for consolidation and 563 days treatment-free interval for maintenance
Blinatumomab is approved by Food and Drug Administration FDA and European Medicines Agency EMA for use in people with another type of acute leukemia called acute lymphoblastic leukemia ALL but not MPAL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None