Overview

This trial is active, not recruiting.

Condition relapsed/refractory philadelphia positive b-precursor acute lymphoblastic leukemia
Treatment blinatumomab
Phase phase 2
Target CD19
Sponsor Amgen
Start date January 2014
End date May 2015
Trial size 45 participants
Trial identifier NCT02000427, 20120216

Summary

This study seeks adult subjects with R/R Ph+ B-precursor ALL. This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable subjects), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, subjects will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All subjects will receive open label Blinatumomab
blinatumomab
Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval. In the first cycle, the initial dose will be 9 μg/day for the first 7 days of treatment, a dose that then will be escalated (dose step) to 28 μg/day starting at day 8 (week 2) through day 29 (week 4). For all subsequent cycles (beginning with the second induction cycle and continuing through consolidation for applicable subjects), 28 μg/day will be the dose for all 4 weeks of continuous treatment.

Primary Outcomes

Measure
Number of Participants with CR/CRh* within 2 cycles of treatment with blinatumomab
time frame: Approximately 12 weeks

Secondary Outcomes

Measure
Number of Participants with MRD remission within 2 cycles of treatment with blinatumomab
time frame: Approximately 12 weeks
Duration of CR or CRh*
time frame: Approximately 3 - 4 years
Number of Participants with CR within 2 cycles of treatment with blinatumomab
time frame: Approximately 12 weeks
Number of Participants with CRh* rate within 2 cycles of treatment with blinatumomab
time frame: Approximately 12 weeks
Number of Participants with CR+CRh*+ Complete Response incomplete (CRi) rate within 2 cycles of treatment with blinatumomab
time frame: Approximately 12 weeks
Overall survival
time frame: Approximately 3 - 4 years
Number of Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) and 100-day mortality after alloHSCT
time frame: 100 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability and number of participants withIncidence of adverse events and antibody formation
time frame: Approximately 2 - 3 years
Serum concentration of blinatumomab
time frame: Approximately 2 - 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Patients with Ph+ B-precursor ALL, with any of the following: • Relapsed or refractory to at least one second generation 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

Additional Information

Official title A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Amgen.