Activated Immune Cells in Treating Patients with Hematologic Cancers That Have Relapsed after Donor Stem Cell Transplant

Inclusion Criteria

• INCLUSION CRITERIA FOR ENROLLMENT: Hematologic malignancy >= 6 months after allogeneic hematopoietic cell transplant (alloHCT) employing PTCy as GVHD prophylaxis with active bone marrow relapse or minimal residual disease (MRD), involving the bone marrow documented at any time point post-transplant * MRD is defined by the following criteria: 1) Detection of blasts with a flow cytometric leukemia-associated immunophenotype (LAIP); 2) Detection of AML-defining genetic markers such as FLT3-ITD and NPM1 mutations, other mutations found in the patient’s original leukemia, karyotypic abnormalities, or fusion transcripts such as CBFB/MYH11 or RUNX1/RUNXT1 * Patients who received chemotherapy after documented relapse and/or MRD posttransplant and achieve remission will be still eligible for this study even without active disease or MRD at the time of the screening/registration
• INCLUSION CRITERIA FOR ENROLLMENT: Donor cluster of differentiation (CD)3+ chimerism >= 30% measured in peripheral blood or bone marrow
• INCLUSION CRITERIA FOR ENROLLMENT: Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky performance scale (KPS) >= 70%
• INCLUSION CRITERIA FOR ENROLLMENT: The patient has been off all immunosuppression for at least 2 weeks at the time of PTCy-MILs collection
• INCLUSION CRITERIA FOR ENROLLMENT: Expectation of ability to safely undergo salvage treatment appropriate for the patient’s malignant disease type
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Confirmation of active relapse involving the bone marrow of a hematologic malignancy >= 6 months after alloHCT employing PTCy as GVHD prophylaxis and more than 90 days after PTCy-MILs infusion
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Donor CD3+ chimerism >= 30% measured in peripheral blood or bone marrow
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky performance scale (KPS) >= 70%
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No active acute infections
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No requirement for systemic steroids
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: White blood cell count (WBC) >= 2,000/uL
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Absolute neutrophil count (ANC) >= 1,500/uL
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Platelets >= 100,00/uL (transfusions are permitted)
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Hemoglobin >= 9.0 g/dL (transfusions are permitted)
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: AST (aspartate aminotransferase) =< 3 x ULN
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: ALT (alanine aminotransferase) =< 3 x ULN
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Bilirubin =< 1.5 x ULN
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
• INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Expectation of ability to safely undergo salvage treatment appropriate for the patient’s malignant disease type

Exclusion Criteria

• EXCLUSION CRITERIA FOR ENROLLMENT: Most recent alloHCT performed did not utilize PTCy GVHD prophylaxis
• EXCLUSION CRITERIA FOR ENROLLMENT: The presence of active GVHD requiring treatment
• EXCLUSION CRITERIA FOR ENROLLMENT: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILs
• EXCLUSION CRITERIA FOR ENROLLMENT: Creatinine >= 2.5 times the upper limit of normal (ULN)
• EXCLUSION CRITERIA FOR ENROLLMENT: Total bilirubin > 3 times the ULN
• EXCLUSION CRITERIA FOR ENROLLMENT: AST (aspartate aminotransferase)/ALT (alanine aminotransferase) > 3 times the ULN
• EXCLUSION CRITERIA FOR ENROLLMENT: Human immunodeficiency virus (HIV)-1/2 or human T-cell lymphotropic virus (HTLV)-1/2 positivity
• EXCLUSION CRITERIA FOR ENROLLMENT: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist which would preclude assessment of toxicity of PTCy-MILs
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: More than 2 years have elapsed since the patient’s initial PTCy-MILs infusion
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Most recent alloHCT performed did not utilize PTCy GVHD prophylaxis
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The presence of active GVHD requiring treatment
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILs
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Creatinine >= 2.5
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Total bilirubin > 3 times the upper limit of normal (ULN)
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: AST (aspartate aminotransferase)/ALT (alanine aminotransferase) > 3 times the ULN
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: HIV-1/2 or HTLV-1/2 positivity
• EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist