Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL

NCT06886074 | Recruiting Phase 2

• 1 other identifier: HE25-00007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)

Conditions

Acute Lymphoblastic Leukemia; Measurable Residual Disease (MRD)

Keywords

Blinatumomab; Measurable residual disease

Outcome Measures

Primary Outcomes (1)

• Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia

  Primary outcome is to determinate the efficacy of blinatumomab to eradicate MRD in a blood sample extracted by bone marrow aspiration and evaluated by next generation flow cytometry on the third day after blinatumomab completion (day 10 after initiation). MRD eradication will be defined as: undetectable (below limit of detection) disease through next generation flow cytometry.

  24 months

Secondary Outcomes (6)

• Overall survival

  24 months

• Disease free survival

  24 months

• Percentage of patients undergoing stem cell transplantation

  24 months

• Incidence of adverse events

  24 months

• Incidence of cytokine release syndrome

  24 months

Study Arms (1)

Blinatumomab arm

EXPERIMENTAL

Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days

Drug: Short course of blinatumomab

Interventions

Short course of blinatumomab DRUG

Patients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion. Blinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose.

Blinatumomab arm

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
• MRD detectable in complete response (above the limit of quantification according to FCM)
• Performance status 0-2 on the ECOG scale
• No prior organ damage
• Having a potential related or unrelated donor

You may not qualify if:

• Performance status on the ECOG scale \>2
• HCT-CI \>3 points
• Patients who do not wish to participate in clinical study.
• Active central nervous system infiltration (CNS3)
• Active extramedullary disease
• Having previously received blinatumomab
• Absence of related or unrelated donors

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (1)

• Yin J, Cai X, Qian B, Liu Y, Li D. Short-Course Blinatumomab Treatment as a Bridge to Further Salvage Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia: A Retrospective Single-Center Study. Cancer Med. 2024 Dec;13(24):e70515. doi: 10.1002/cam4.70515.

  PMID: 39692275 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andres Gomez-De Leon, Professor of Hematology

CONTACT

+528116089404; drgomezdeleon@gmail.com

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: Head of Hematology

Model Details: One arm, open-label, phase 2 study

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 20, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

ME (1)