Phase 2
N=116
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
B-cell Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01207388 ↗Enrolled (actual)
116
Serious AEs
62.9%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle — 77.0 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 Research (Munich) GmbH
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle |
77.0 | — |
| SECONDARY Hematological Relapse-free Survival (RFS) |
54 | — |
| SECONDARY Overall Survival |
36.5 | — |
| SECONDARY 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant |
7 | — |
| SECONDARY Time to Hematological Relapse |
NA | — |
| SECONDARY Duration of Complete MRD Response |
45.0 | — |
| SECONDARY Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
116; 73; 71; 33; 2; 20 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-C30 Scales |
9.0; 3.9; 2.6; 2.2; 12.2; 1.4 | — |
| SECONDARY Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales |
-0.2; 0.0; -0.1; 0.0; -0.1; -0.1 | — |
| SECONDARY Resource Utilization: Number of Participants Reporting Use of Transfusion of Blood Products |
14; 5; 8; 0; 1; 0 | — |
| SECONDARY Resource Utilization: Duration of Hospitalization |
14.0 | — |
Summary
The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.
Eligibility Criteria
Inclusion Criteria
- Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
- Presence of minimal residual disease at a level of ≥ 10^-3
- Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
- Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
- Negative pregnancy test in women of childbearing potential
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- Presence of circulating blasts or current extra-medullary involvement by ALL
- History of relevant central nervous system (CNS) pathology or current CNS pathology
- Prior allogeneic hematopoietic stem cell transplant (HSCT)
- Eligibility for treatment with tyrosine-kinase inhibitors (TKI)
- Systemic cancer chemotherapy within 2 weeks prior to study treatment
- Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
- Previous treatment with blinatumomab
Data sourced from ClinicalTrials.gov (NCT01207388). 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.