Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant
Minimal Residual Disease, Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Recurrent Adult Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Minimal Residual Disease
Eligibility Criteria
Inclusion Criteria:
- AML relapse following Allo-HSCT (Morphological relapse, or MRD positive verified by flow cytometry, cytogenetics, and molecular mutations)
- Relapsed/Refractory AML must not be candidates for available therapies known to be effective for treatment of their AML.
- MDS transformed to AML following Allo-HCT
- Patients who received a 10/10 HLA-matched allogeneic HCT either from sibling donors or unrelated donors or atleast a 5/10 haploidentical transplant.
Engraftment must have occurred as defined by platelet (PLT) count > 20,000/µL and ANC
- 0.5
- Eastern Cooperative Oncology Group (ECOG) performance status < 3
- Creatinine clearance > 40 ml/min (calculated or measured)
- Aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN), alanine aminotransferase (ALT) < 3 x ULN
- Total bilirubin < 1.5 x ULN
- Off calcineurin inhibitors for at least 2 weeks
- Prednisone dose ≤ 20 mg/day
- Patients with proliferative disease can be cytoreduced with cytotoxic chemotherapy at Investigator discretion, but there should be at least a 14 day window between start of cytoreductive therapy and start of daratumumab
- Blast count ˂20K/day (hydrea use is allowed)
Exclusion Criteria:
- No demonstrable evidence of donor chimerism (˂ 55% donor CD3 or CD33 chimerism)
- Patients with a molecular mutation without chromosomal abnormalities or declining chimerisms (MRD status must be verified by surface marker and mutational analyses)
- Active graft-versus-host disease (GvHD) grades II-IV; prior acute GVHD could have occurred but resolved at time of initiation of daratumumab
- Extensive chronic GvHD requiring ongoing immunosuppression with calcineurin inhibitors
- Patients with FLT3+ AML or blast crisis CML who have not yet received post-transplant TKI therapy
- Active central nervous system (CNS) disease testicular disease
EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.; seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
- History of grade IV anaphylactic reaction to monoclonal antibody therapy
- Active autoimmune disease prior to transplant
- Concurrent use of any other investigational drugs
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (DLI, daratumumab)
Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity.