CD8+ Memory T-Cells as Consolidative Therapy after Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients with Leukemia or Lymphoma

Inclusion Criteria

• Has a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor
• Has a myeloid or lymphoid malignant disease that is treated with TLI and ATG reduced-intensity conditioning for allogeneic transplant (any of the following: acute myeloid leukemia [AML]; chronic lymphocytic leukemia [CLL]; B or T cell non-Hodgkin lymphoma [NHL]; Hodgkin lymphoma [HL]; myelodysplastic syndrome [MDS]; or myeloproliferative disease syndrome [MPD])
• Patients who due to age, pre-existing medical conditions, or, prior therapy are considered to be at high-risk for regimen-related toxicity associated with fully ablative transplant conditioning, and therefore reduced intensity conditioning is recommended
• Ability to understand and the willingness to sign a written informed consent document; patients must have signed informed consent to participate in the trial
• DONOR: HLA-matched or single allele mismatched sibling of enrolled transplant patient
• DONOR: Must be 18-80 years of age, inclusive
• DONOR: In a state of general good health and have completed a donor evaluation with history, medical examination and standard blood tests within 60 days of starting the hematopoietic cell collection procedure; in order to fairly represent the interests of the donor, the donor evaluation and consent will be performed by a study team member other than the recipient’s attending physician
• DONOR: White blood cell count > 3.5 x 10^9/liter, platelets > 150 x 10^9/liter and hematocrit > 35%
• DONOR: Capable of undergoing leukapheresis
• DONOR: Able to understand and sign informed consent
• DONOR: Hepatitis A, B and C, human immunodeficiency virus (HIV) 1 and 2, human T-lymphotropic virus (HTLV), varicella zoster virus (VZV), Epstein-Barr virus (EBV), herpes simplex virus (HSV), West Nile virus, Syphilis Treponema, T cruzi (Chagas), cytomegalovirus (CMV), and the MPX nucleic acid test (NAT) individual donor testing (IDT) (HIV/hepatitis C virus [HCV]/hepatitis B virus [HBV]) will be tested as per national standard of care guidelines for transplant donors; donors who are HIV positive will be excluded; donors who are positive by serology for hepatitis B or C are eligible as long as polymerase chain reaction (PCR) for ribonucleic acid (RNA)/deoxyribonucleic acid (DNA) is negative
• DONOR: Females must not be pregnant or lactating
• DONOR: No psychological traits or psychological or medical conditions which make them unlikely to tolerate the procedure
• DONOR: Has not developed a new malignancy requiring chemotherapy or radiation in the interval since apheresis for initial hematopoietic cell transplantation (HCT)
• PATIENT CRITERIA FOR PROCEEDING WITH CD8+ MEMORY T-CELL INFUSION:
• Patients must be beyond day 30 and before day 75 after transplant
• Patients must have evidence of mixed CD3 T-cell chimerism based on the day +28 (+/- 7 days) blood sample showing >= 30% and =< 90% donor type cells
• Patients must have no evidence of active graft-versus-host disease at the time of the CD8+ memory T-cell infusion; patients with a history of acute GVHD overall grade II based on skin only involvement or upper gastrointestinal (GI) tract involvement only will be eligible; patients with a history of liver or lower GI tract GVHD will not be eligible
• Patient must not have clinical evidence of disease progression prior to the CD8+ memory T-cell infusion
• Patients must be on single immune suppression therapy with either tacrolimus or cyclosporine at the time of CD8+ memory T-cell infusion; prednisone at a physiologic dose of 5 mg per day or less is allowed
• Patients must have a Karnofsky performance status of >= 60% at the time of the CD8+ memory T-cell infusion
• Patients must not have an uncontrolled bacterial, fungal or viral infection, defined as progressive symptoms despite therapy, at the time of the CD8+ memory T-cell infusion; asymptomatic viremia is allowed
• Patients must have adequate organ function and performance status at the time of the CD8+ memory T-cell infusion, defined by the following: * Total bilirubin =< 4 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 4 x upper limit of normal (ULN) * Creatinine =< 3 mg/dL or estimated creatinine clearance >= 40 ml/min

Exclusion Criteria

• Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms
• Progressive hemato-lymphoid malignancy despite conventional therapy
• Acute leukemia not in remission
• Chronic myelogenous leukemia (CML)
• Active central nervous system (CNS) involvement of the underlying malignancy
• HIV-positive
• Pregnant or lactating
• Prior malignancy (EXCEPTION: diagnosed > 5 years ago without evidence of disease, OR treated =< 5 years ago but have a greater than 50% chance of life expectancy of >= 5 years for that malignancy)
• Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant
• Ejection fraction < 30%, or uncontrolled cardiac failure
• Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted
• Total bilirubin > 3 mg/dL
• SGOT or SGPT > 4 x ULN
• Creatinine > 2 mg/dL and an estimated creatinine clearance =< 40 mL/min
• Poorly controlled hypertension despite multiple antihypertensive medication or
• Karnofsky performance status (KPS) < 60%
• Note: Patients positive for hepatitis B and C will be evaluated on a case by case basis