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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-60
SponsorHospital Universitario Dr. Jose E. Gonzalez

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Blinatumomab armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

1

Overall survival

Survival time after enrollment

Time frame
24 months
2

Disease free survival

Time from enrollment to relapse

Time frame
24 months
3

Percentage of patients undergoing stem cell transplantation

Percentage of patients who undergo hematopoietic stem cell transplantation after enrollment

Time frame
24 months
4

Incidence of adverse events

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

Other outcomes

Sponsors and contacts

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