Phase 2
N=36
Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
B-ALL
Bottom Line
View on ClinicalTrials.gov: NCT01209286 ↗Enrolled (actual)
36
Serious AEs
66.7%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment — 71.4; 69.6; 66.7; 69.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blinatumomab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen Research (Munich) GmbH
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment |
71.4; 69.6; 66.7; 69.4 | — |
| SECONDARY Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment |
14.3; 43.5; 66.7; 41.7 | — |
| SECONDARY Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment |
57.1; 26.1; 0.0; 27.8 | — |
| SECONDARY Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment |
0.0; 8.7; 0.0; 5.6 | — |
| SECONDARY Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study |
71.4; 73.9; 50.0; 69.4 | — |
| SECONDARY Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab |
42.9; 60.9; 16.7; 50.0 | — |
| SECONDARY Time to Hematological Relapse |
240.0; NA; NA; 270.0 | — |
| SECONDARY Relapse-free Survival |
137.0; 268.0; NA; 233.0 | — |
| SECONDARY Overall Survival |
269.0; 300.0; NA; 300.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
7; 23; 6; 36; 7; 15 | — |
| SECONDARY Steady State Blinatumomab Concentration |
167; 553; 1180 | — |
| SECONDARY Clearance of Blinatumomab |
1.34 | — |
| SECONDARY Serum Cytokine Peak Levels |
2563; 212; 21; 1302; 351; 419 | — |
Summary
The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor ALL.
Eligibility Criteria
Inclusion Criteria
- Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
- More than 5% blasts in bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of ≥ 12 weeks
Exclusion Criteria
- History or presence of clinically relevant central nervous system (CNS) pathology
- Infiltration of cerebrospinal fluid (CSF) by ALL
- Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six weeks/three months prior to start of blinatumomab treatment
- Active Graft-versus-Host Disease (GvHD)
- Patients with Philadelphia chromosome (Ph)+ ALL eligible for treatment with dasatinib or imatinib
- Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
- Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
- Infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
- Pregnant or nursing women
- Previous treatment with blinatumomab
Data sourced from ClinicalTrials.gov (NCT01209286). 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.