Relapse Prophylaxis With IL-15 Super Agonist N-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation
This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803 formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
• Diagnosis of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant using a reduced intensity conditioning is planned or has been performed and patient is prior to day 60 post-transplant.
• Able to begin study treatment between day +42 and day +60 after the transplant and meets the following transplant related requirements:
‣ Sustained neutrophil (ANC \> 1000/mcL) and platelet (\> 30,000/mcL) engraftment
⁃ \>50% donor myeloid and lymphoid chimerism blood or bone marrow on most recent bone marrow (BM) evaluation
⁃ No evidence of recurrent disease on most recent bone marrow evaluation (day 21 or 28 post-transplant is acceptable)
⁃ No morphologic evidence of relapse (\< 5% bone marrow blasts) on most recent BM evaluation (Day 21 or 28 post-transplant is acceptable)
⁃ Being followed in the outpatient setting (not an inpatient)
⁃ No plan of giving other anti-cancer treatment directed at diseases under study (i.e. maintenance therapy \[e.g. sorafenib for FLT3m+ AML or hypomethylating therapy\], additional therapy for MRD)
• If acute GVHD is present it must be clinically improving on topical steroids and/or on low dose systemic steroids (≤ 0.3 mg/kg/day prednisone) and with clinical stability for at least 1 week prior to determination of eligibility. GVHD prophylaxis will be continued per individual institutional standard practice
• One of the following donor graft sources used for the transplant:
‣ Group 1: sibling donor
⁃ Group 2: haploidentical donor \[with post-transplant cyclophosphamide\]
⁃ Group 3: unrelated donor
⁃ Group 4: unrelated umbilical cord blood
• Karnofsky performance status ≥ 70%
• Adequate organ function within 14 days of study enrollment defined as:
‣ Renal: serum creatinine: ≤ 2.0 mg/dL
⁃ Hepatic: SGOT ≤ 3 x upper limit of institutional normal (ULN)
• Sexually active females of child-bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy.
• Voluntary written consent prior to the performance of any research related procedures