Clinical trial NCT06886074: Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Official title: Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Measurable Residual Disease (MRD)
Keywords: Blinatumomab
Measurable residual disease
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm, open-label, phase 2 study
Primary purpose: TREATMENT

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)

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.

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

Primary outcomes:
measure: Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Disease free survival
timeFrame: 24 months
measure: Percentage of patients undergoing stem cell transplantation
timeFrame: 24 months
measure: Incidence of adverse events
timeFrame: 24 months
measure: Incidence of cytokine release syndrome
timeFrame: 24 months
measure: Incidence of immune effector cell-associated neurotoxicity syndrome
timeFrame: 24 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
References:
citation: 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.