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Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT | Clinical Trials | Clareo Health

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

Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study

NCT06075238•Sichuan University

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
•2. Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
•3. KPS \> 60 or ECOG 0-2;
•4. The expected survival time is more than 3 months;
•5. Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
•6. 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;
•7. No central nervous system involvement or clinical symptoms after transplantation;
•8. Those who have no serious functional damage to important organs of the body;
•9. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
+1 more criteria

Exclusion Criteria

•1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
•2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
•3. 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;
•4. Poor graft function (PGF) occurred after allo-HSCT;
•5. Combined with other malignant tumors and require treatment;
•6. Active GVHD;
•7. Have a history of allergy to Chidamide;
•8. Pregnant or lactating females;
•9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
•10. Patients with active chronic hepatitis B or active hepatitis C;
+2 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

October 1, 2023

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2026

Last Updated

October 10, 2023

Enrollment

ESTIMATED participants

Conditions

Leukemia, Lymphoid

Interventions

blinatumomab

DRUG

Contacts

Jie Ji, MD

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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