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Cytarabine

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Blinatumomab

14d screening period: methotrexate, cytarabine, dexamethasone infusion i.th.

Cycle 1 (all patients): d1-28: blinatumomab continuous infusion i.v., d4: allogeneic donor lymphocyte single infusion i.v., d29: methotrexate, cytarabine, dexamethasone infusion i.th.

Cycle 2 (only patients with toxicity ≤ grade 2 CTCAE in cycle 1): d43-d70: blinatumomab continuous infusion i.v., d46: allogeneic donor lymphocyte single infusion i.v., d71: methotrexate, cytarabine, dexamethasone infusion i.th.

Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion

Blinatumomab in combination with donor lymphocyte infusion

Marion Subklewe, MD

Christian Schmidt, MD

Sascha Haubner, MD

This phase 2 study is designed to evaluate the safety, tolerability and efficacy of allogeneic donor lymphocyte infusions (DLI) combined with the bispecific T cell engager blinatumomab in B-precursor ALL patients who have mixed chimerism (MC) or are MRD-positive after allogeneic SCT and are refractory to at least one MRD- or MC-targeted therapy (i.e. blinatumomab, DLI, tyrosine kinase inhibitors or other agents).

Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab in Patients With Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia After Allogeneic Stem Cell Transplantation

Subject incidence and grade of adverse events (AEs) including graft-versus-host disease (GvHD). The intensity of (S)AEs will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

MRD response based on RT-PCR: Complete MRD response (MolCR): hCR and MRD not detectable by molecular probe\[s\] with a sensitivity ≥10-4. The MRD response is calculated as: \[number of patients achieving complete MRD response after at least one cycle (minimum 4 days blinatumomab) of study treatment\] / \[number of patients who received at least 1 cycle (minimum 4 days blinatumomab) of study treatment\].

Mixed chimerism response: CC response: only donor STRs in bone marrow; Low-level MC response ≥90% but \<100% donor STRs in bone marrow. The MC response is calculated as: \[number of patients achieving CC/low-level MC response after at least one cycle (minimum 4 days blinatumomab) of study treatment\] / \[number of patients who received at least 1 cycle (minimum 4 days blinatumomab) of study treatment\].

For patients who received at least one cycle (minimum 4 days of blinatumomab), progression-free survival and overall survival will be calculated using kaplan-meier survival estimates. Descriptive summary statistics (N, mean, standard deviation, minimum, median and maximum) for the duration of response will be performed for all patients with an observed complete MRD response or CC/low-level MC response.

Amgen

Ludwig-Maximilians - University of Munich

Deputy Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab	NCT03982992	B Cell Precurso... B-Cell Acute Ly... Acute Lymphobla... Acute Lymphobla... Acute Lymphobla...	Blinatumomab in...	18 Years -	Ludwig-Maximilians - University of Munich
Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab	NCT03982992	B Cell Precurso... B-Cell Acute Ly... Acute Lymphobla... Acute Lymphobla... Acute Lymphobla...	Blinatumomab in...	18 Years -	Ludwig-Maximilians - University of Munich

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