Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

NCT06075238 | Not Yet Recruiting Phase 2

• 1 other identifier: PT-Blin 1.0
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Conditions

Leukemia, Lymphoid

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  Progression free survival of this group of patients at the end of 2 year

  2 years

• 100 day adverse events (AE)

  non-hematologic adverse events

  Day +100

Secondary Outcomes (5)

• Non-relapse mortality (NRM)

  6 months

• Relapse rate

  2 years

• Overall survival (OS)

  2 years

• Cumulative incidence of acute graft versus host disease (aGVHD)

  Day +100

• Cumulative incidence of chronic graft versus host disease (cGVHD)

  2 years

Study Arms (1)

blinatumomab

EXPERIMENTAL

Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Drug: blinatumomab

Interventions

blinatumomab DRUG

The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

blinatumomab

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:

• B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
• Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
• KPS \> 60 or ECOG 0-2;
• The expected survival time is more than 3 months;
• Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
• Reach the standard of hematopoietic reconstitution (neutrophil count
• ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation;
• No central nervous system involvement or clinical symptoms after transplantation;
• Those who have no serious functional damage to important organs of the body;
• Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
• Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

You may not qualify if:

• Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
• Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
• Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
• Poor graft function (PGF) occurred after allo-HSCT;
• Combined with other malignant tumors and require treatment;
• Active GVHD;
• Have a history of allergy to Chidamide;
• Pregnant or lactating females;
• Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
• Patients with active chronic hepatitis B or active hepatitis C;
• History of prolonged QT syndrome;
• Patients considered by other researchers to be unsuitable for this study

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jie Ji, MD

CONTACT

86-28-85422373; jieji@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)