NCT Number: NCT06886074
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)
Interested in participating?
Request Info16 year–60 year
All sexes
Interventional
Phase 2
Monterrey, Nuevo León, 64460, Mexico
Location status: Recruiting
Andres Gomez De Leon, Professor of Hematology
CONTACT
Andres Gomez De Leon, Proffesor of Hematology
PRINCIPAL_INVESTIGATOR
David Gomez Almaguer, Head of Hematology Service
SUB_INVESTIGATOR
David Gomez-Almaguer, Head of Hematology Service
CONTACT
Francisco J Rubio Macias, Fellow of Hematology
SUB_INVESTIGATOR
Luis P. Ugarte Pelaez, Fellow of Hematology
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 months
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.
Time frame: 24 months
Survival time after enrollment
Time frame: 24 months
Time from enrollment to relapse
Time frame: 24 months
Percentage of patients who undergo hematopoietic stem cell transplantation after enrollment
Time frame: 24 months
Incidence of hematologic (anemia, thrombocytopenia, leukopenia, neutropenia, lymphocytopenia) and non-hematologic (renal, hepatic, dermatologic, cardiovascular, infectious) adverse events after initiating blinatumomab therapy assessed by CTCAE V 5.0
Time frame: 24 months
Incidence and grading of cytokine release syndrome after initiating blinatumomab through CTCAE V 5.0
Time frame: 24 months
Incidence and grading of immune effector cell-associated neurotoxicity syndrome after initiating blinatumomab assessed by ASTCT grading system.
Contact information is provided by the study sponsor or research team.
Hospital Universitario Dr. Jose E. Gonzalez
Other
Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
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