Phase 2
N=45
Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
Relapsed/Refractory Philadelphia Positive B-precursor ALL
Bottom Line
View on ClinicalTrials.gov: NCT02000427 ↗Enrolled (actual)
45
Serious AEs
62.2%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles — 35.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blinatumomab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles |
35.6 | — |
| SECONDARY Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment |
40.0 | — |
| SECONDARY Duration of CR or CRh* Response |
6.7 | — |
| SECONDARY Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles |
31.1 | — |
| SECONDARY Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles |
4.4 | — |
| SECONDARY Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles |
40.0 | — |
| SECONDARY Overall Survival |
7.1 | — |
| SECONDARY Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission |
43.8 | — |
| SECONDARY 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant |
25.0 | — |
| SECONDARY Number of Participants With Adverse Events |
45; 37; 18; 28; 3; 16 | — |
| SECONDARY Number of Participants Who Developed Anti-blinatumomab Antibodies |
— | — |
| SECONDARY Steady State Concentration of Blinatumomab |
449; 532 | — |
Summary
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
Eligibility Criteria
Inclusion Criteria
- Patients with Ph+ B-precursor ALL, with any of the following:
- Relapsed or refractory to at least one second generation tyrosine kinase inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)
- OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
- Greater than 5% blasts in bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years of age, at the time of informed consent.
- Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Exclusion Criteria
- History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease
- History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis
- Active ALL in the CNS or testes
- Isolated extramedullary disease
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment
- Active acute or extensive chronic graft-versus-host disease (GvHD) which included the administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks before blinatumomab treatment
- immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic HSCT at the time of enrollment.
Data sourced from ClinicalTrials.gov (NCT02000427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.