Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    12
  • sponsor
    Ludwig-Maximilians - University of Munich
Updated on 23 January 2021
renal function
imatinib
tyrosine
dasatinib
ponatinib
bosutinib
gilbert's syndrome
b-cell acute lymphoblastic leukemia
blinatumomab
cellular therapy
nilotinib
bcr-abl protein

Summary

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).

Details
Condition childhood ALL, Acute Lymphoblastic Leukemia in Remission, Lymphocytic Leukemia, Acute, B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation, B-Cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Adult, B-Cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Adult, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), B-Cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Adult
Treatment Blinatumomab in combination with donor lymphocyte infusion
Clinical Study IdentifierNCT03982992
SponsorLudwig-Maximilians - University of Munich
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Acute Lymphoblastic Leukemia in Remission or B-Cell Acute Lymphoblastic Leukemia or childhood ALL or B Cell Precursor Acute Lymphoblastic Leukemia Wit...?
Do you have any of these conditions: B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation or Acute Lym...?
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
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
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
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
Availability of allogeneic donor lymphocytes from the subject's donor (at least 2 x 10^8 T cells/kg)
Subject has provided written informed consent prior to initiation of any study-specific activities/procedures
Subject has provided informed consent to be followed up in the GMALL-Registry
Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Renal function as follows: serum creatinine < 2.0 mg/dL and estimated glomerular filtration rate > 30 mL/min
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)
For female subjects only: Women of child-bearing age have to use a reliable method of contraception

Exclusion Criteria

Eligibility for treatment with blinatumomab ALONE or other antibody-based treatment approaches (e.g. inotuzumab ozogamicin), as considered by the treating physician
Eligibility for standard chemotherapy, as considered by the treating physician
Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives (whichever is longer) prior to baseline MRD and/or chimerism assessment
Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment
Any grade of GvHD currently requiring treatment
Clinically relevant central nervous system (CNS) pathology requiring treatment (e.g., unstable epilepsy)
Evidence of current CNS involvement by ALL
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