Phase 2
N=189
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01466179 ↗Enrolled (actual)
189
Serious AEs
64.0%
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 — 42.9 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
- Oct 2013
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 |
42.9 | — |
| SECONDARY Time to Hematological Relapse (Duration of Response) |
6.7 | — |
| SECONDARY Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission |
39.5 | — |
| SECONDARY Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment |
33.3 | — |
| SECONDARY Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment |
9.5 | — |
| SECONDARY Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment |
2.6 | — |
| SECONDARY Relapse-free Survival |
5.9 | — |
| SECONDARY Event-free Survival |
0.0 | — |
| SECONDARY Overall Survival |
6.1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
188; 155; 166; 105; 121; 105 | — |
| SECONDARY 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant |
11.3 | — |
| SECONDARY Serum Blinatumomab Concentration at Steady State |
211; 621; 731 | — |
| SECONDARY Serum Cytokine Peak Levels |
93.1; 27.4; 22.8; 21.6; 589; 95.7 | — |
| SECONDARY Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment |
9.0 | — |
| SECONDARY Best Response During the Core Study |
43.4; 35.4; 7.9; 9.0; 2.6 | — |
Summary
The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).
Eligibility Criteria
Inclusion Criteria
- Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following:
- relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
- relapsed or refractory after first salvage therapy or
- relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT)
- 10% or more blasts in bone marrow
- In case of clinical signs of additional extramedullary disease: measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years
Exclusion Criteria
- Patients with Ph-positive ALL
- Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
- History or presence of clinically relevant central nervous system (CNS) pathology
- Active ALL in the CNS or testes
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Autologous HSCT within six weeks prior to start of blinatumomab treatment
- Allogeneic HSCT within three months prior to start of blinatumomab treatment
- Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4
- Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
- Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
- Radiotherapy within two weeks prior to start of blinatumomab treatment
- Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment
- Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
- Treatment with any other investigational medicinal product (IMP) after signature of informed consent
- Eligibility for allogeneic HSCT at the time of enrollment
- Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
- Abnormal laboratory values indicative of inadequate renal or liver function
- History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
- Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
- Pregnant or nursing women
- Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child
- Previous treatment with blinatumomab
Data sourced from ClinicalTrials.gov (NCT01466179). 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.