Blinatumomab Maintenance After Allo-HSCT
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorRuijin Hospital
About this trial
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 16-65 years
Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
High-risk group B-ALL
Have suitable hematopoietic stem cell donors
Disqualifiers
CR/MRD negative before blinatumomab maintenance
Active hepatitis B
HIV-infected
Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
Trial design
Design model
Parallel
Treatments tested in this trial
Blinatumomab
DrugMaintenance therapy with Blinatumomab initiation: 90 days to 120 days post-transplantation
Treatment groups
59 Participants
are divided into 2 treatment groupsGroup A: Blinatumomab groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
2-year Event-free survival
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
2-year relapse rate
Time frame
through study completion, an average of 2 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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