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Recruiting NCT06886074

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

Phase II Interventional Acute Lymphoblastic Leukemia Measurable Residual Disease (MRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short course of blinatumomab.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Measurable Residual Disease (MRD). Basic parameters: 16 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia

Overview

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)

Detailed description

During the proposed treatment, blinatumomab therapy will be assigned as follows:

Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.

The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.

Interventions

  • Drug Short course of blinatumomab
    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.

Primary outcome measures

  • Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia [Time frame: 24 months]
Secondary outcome measures (6)
  • Overall survival [Time frame: 24 months]
  • Disease free survival [Time frame: 24 months]
  • Percentage of patients undergoing stem cell transplantation [Time frame: 24 months]
  • Incidence of adverse events [Time frame: 24 months]
  • Incidence of cytokine release syndrome [Time frame: 24 months]
  • Incidence of immune effector cell-associated neurotoxicity syndrome [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Hospital Universitario Dr. Jose E. Gonzalez — Monterrey

Publications

  • 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

Identifiers

NCT: NCT06886074 · HE25-00007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗