Blinatumomab Maintenance After Allo-HSCT

NCT06438796 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TROPHY-ALL01
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.

Conditions

High Risk Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 2-year Event-free survival

  through study completion, an average of 2 year

Secondary Outcomes (1)

• 2-year relapse rate

  through study completion, an average of 2 year

Study Arms (2)

Blinatumomab group

EXPERIMENTAL

Blinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d)

Drug: Blinatumomab

Control group

NO INTERVENTION

Maintenance therapy in the control group was based on the routine maintenance therapy in each center (including but not limited to decitabine, sorafenib, prophylactic DLI, except for all types of CD19 mono- and dual-antibodies and CD22-ADC drugs).

Interventions

Blinatumomab DRUG

Maintenance therapy with Blinatumomab initiation: 90 days to 120 days post-transplantation

Blinatumomab group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No dysfunction of vital organs

You may not qualify if:

• CR/MRD negative before blinatumomab maintenance
• Active hepatitis B
• HIV-infected
• Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
• severe impairment of vital organ function
• Those judged by the investigator to be unsuitable for participation in this trial.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Interventions

blinatumomab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 3, 2024

Record last verified: 2024-05