Blinatumomab Consolidation in Real World

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

This will be a multi-center registry for patients with B-ALL. Patient data will be collected both retrospectively and prospectively. The data forms and surveys will be built and managed through REDCap, a secure web application managed by the Clinical \& Translational Science Institute.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1) aged 18 years or older 2) diagnosed with B-ALL on or after December 1st 2022 3) Not received blinatumomab in an interventional clinical trial setting 4) Willing and able to give informed consent (or retrospective data for deceased patients

Disqualifiers

N/A

Trial population

Patients with B-ALL diagnosed during or after December 2022

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Patients who received Blinatumomab Therapy
Group B: Patients who did not receive Blinatumomab Therapy

Trial outcomes

Primary outcomes

1

Percentage of participants with complete remission

Complete remission as defined by patients having no lymphoblasts in the marrow or blood

Time frame
5 years or e.g., 1 year after closure of study

Secondary outcomes

1

Overall Survival

Percentage of participants overall survival (OS). OS will be calculated from the time of diagnosis of to death from any cause, and patients will be censored if they were alive at the last follow-up

Time frame
5 years

Other outcomes

Sponsors and contacts

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