NL-OMON55298CompletedNot Applicable
A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL) - 20190117 (Blinatumomab + AMG404 combination)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 2
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Age >= 18 years at enrollment.
- •Subjects with B-precursor ALL, with any of the following:
- •-Refractory to primary induction or refractory to salvage therapy.
- •-In untreated first, second or greater relapse or refractory relapse or relapse
- •after salvage therapy
- •-Relapse at any time after allogeneic HSCT:
- •o Relapse is defined as achievement of CR (CR1) during upfront therapy then
- •relapse during or after continuation therapy.
- •o Refractory disease is defined as the absence of CR after standard induction
- •o Refractory relapse lack of CR after first salvage therapy
- •o Second relapse or later relapse defined as relapse after achieving a second
- •CR (CR2) in first or later salvage.
- •Greater than or equal to 5% blasts in the BM.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) <= 2.
- •Negative pregnancy test in women of childbearing potential.
- •Refer to section 5.1 of the protocol.
Exclusion Criteria
- •History or presence of clinically relevant CNS pathology such as epilepsy,
- •childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries,
- •dementia, Parkinson*s disease, cerebellar disease, organic brain syndrome or
- •Presence of ALL in the CNS (confirmed by presence of blast cells in CSF) or
- •Isolated extramedullary disease.
- •Current autoimmune disease or history of autoimmune disease with potential
- •CNS involvement.
- •Allogeneic HSCT within 12 weeks before the start of protocol-specified
- •Active acute or chronic graft versus host disease requiring systemic
- •treatment with immunosuppressive medication.
- •Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular
- •targeted therapy) within 14 days prior to study Day 1 with the exception of
- •intrathecal chemotherapy and/or low dose maintenance therapy (eg vinca
- •alkaloids, mercaptopurine, methotrexate, or hydroxyurea). If subject is
- •eligible for pre phase then all low dose chemotherapy with the exception of
- •intrathecal chemotherapy must be discontinued prior to starting pre phase.
- •Tyrosine kinase inhibitors use in patients with Ph+ ALL is allowed.
- •Immunotherapy (eg rituximab, alemtuzumab) within 4 weeks before start of
- •protocol-specified therapy. Prior treatment (given > 4 weeks prior to protocol
- •therapy) with any CD19-directed therapy (eg, blinatumomab, CD19-directed
- •chimeric antigen receptor T-cell therapy, anti-CD19 antibodies will be allowed).
- •Refer to section 5.2 of the protocol.
Investigators
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