Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

Inclusion Criteria

• •1. Adult patients with CD19+ B-precursor ALL (as determined by immunophenotyping) in hCR (defined as having less than 5% blasts in bone marrow) after allogeneic SCT.
• •2. One, or a combination of the following documented after an interval of at least 2 weeks since cessation of the most recent leukemia-targeting therapy (i.e. chemotherapy, immunotherapy or cellular therapy, except for intrathecal prophylaxis):
• •* Positivity for CD19+ MRD (molecular failure or molecular relapse), defined as presence of MRD at a level of ≥10\^-4 according to an assay with a minimum sensitivity of 10\^-4.
• •* Donor chimerism \<90%, as determined by analysis of host and donor STRs in bone marrow sample engraftment analysis.
• •3. At least one previous line of treatment for MRD-positivity and/or reduced donor chimerism (i.e. blinatumomab, DLI, TKI or other agents) after allogeneic SCT.
• •4. For those with BCR/ABL-positive B-precursor ALL only: persistence of MRD and/or MC following at least one ≥ second generation TKI (dasatinib, nilotinib, bosutinib, ponatinib) OR intolerance to second generation TKI and intolerance to or persistence of MRD and/or MC following imatinib mesylate.
• •5. Availability of allogeneic donor lymphocytes from the subject's donor (at least 2 x 10\^8 T cells/kg).
• •6. Subject has provided written informed consent prior to initiation of any study-specific activities/procedures.
• •7. Subject has provided informed consent to be followed up in the GMALL-Registry.
• •8. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• •9. Renal function as follows: serum creatinine \< 2.0 mg/dL and estimated glomerular filtration rate \> 30 mL/min.
• •10. Hepatic function as follows:
• •* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN)
• •* Alkaline phosphatase (ALP) \< 3.0 x ULN
• •* Bilirubin ≤ 2.0 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
• •11. For female subjects only: Women of child-bearing age have to use a reliable method of contraception.