Overview

This trial is active, not recruiting.

Condition b-all
Treatment blinatumomab
Phase phase 2
Target CD19
Sponsor Amgen Research (Munich) GmbH
Start date October 2010
End date March 2012
Trial size 36 participants
Trial identifier NCT01209286, MT103-206

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
blinatumomab AMG103
Continuous intravenous infusion over four weeks per treatment cycle
(Experimental)
Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
blinatumomab AMG103
Continuous intravenous infusion over four weeks per treatment cycle
(Experimental)
Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
blinatumomab AMG103
Continuous intravenous infusion over four weeks per treatment cycle

Primary Outcomes

Measure
Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment
time frame: Within the first 2 cycles of treatment, 12 weeks

Secondary Outcomes

Measure
Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment
time frame: Within the first 2 cycles of treatment, 12 weeks
Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment
time frame: Within the first 2 cycles of treatment, 12 weeks
Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment
time frame: Within the first 2 cycles of treatment, 12 weeks
Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study
time frame: During the core study treatment period (up to 30 weeks).
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab
time frame: Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days
Time to Hematological Relapse
time frame: Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.
Relapse-free Survival
time frame: Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.
Overall Survival
time frame: Up to the data cut-off date of 15 October 2012; maximum follow up time was 667 days.
Number of Participants With Treatment-emergent Adverse Events
time frame: From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle; median treatment duration was 55.7 days.
Steady State Blinatumomab Concentration
time frame: Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.
Clearance of Blinatumomab
time frame: Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.
Serum Cytokine Peak Levels
time frame: Samples were collected prior to treatment start (baseline), and at 2, 6, 24, and 48 hours after drug infusion start, and at these same time points when dose is escalated in each treatment cycle.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Principal investigator Max Topp, MD
Description Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis and unmet medical need. Additional therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. The purpose of this study is to investigate the efficacy, safety and tolerability of different doses of the bispecific T-cell engager blinatumomab in adult patients with relapsed/refractory B-precursor ALL. Patrticipants will receive up to five 4-week cycles of intravenous blinatumomab treatment.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Amgen Research (Munich) GmbH.