Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Más betegség

• Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
• Patients with known allergy to DMSO.

Egyéb

• Non-compliant patients.
• No appropriate caregivers identified.
• Active central nervous system (CNS) neoplastic involvement.
• Morbid obesity with body mass index >35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).
• HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive.
• Pregnant or breastfeeding women.

• The following criteria are used to enroll patients in the study before transplant.
• Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:
  • Acute myeloid leukemia [AML] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease
  • Chronic myeloid leukemia [CML] in any chronic phase.
  • Myelodysplastic syndrome [MDS] with intermediate/high risk features or refractory disease (with bone marrow blast count <10%).
  • Acute lymphoblastic leukemia [ALL] in morphologic complete remission with high-risk features or relapsed disease.
• Negative test for donor-specific antibody within 28 days of starting conditioning regimen.
• Age Criteria: 19-65 years.
• Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.
  • Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram.
  • Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected.
  • Renal: serum creatinine level to be <2 mg/dl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL/min/1.73 m2.
  • Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN.
• Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80.
• Hematopoietic cell transplant comorbidity index (HCT-CI) <3. Exception may be made on individual cases after discussion with the primary investigator.
• Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
  • The following criteria are required within 48 hours prior to infusion of the EAGD T cell product.
• Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture).
• NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload.
• NO clinically significant organ toxicity that are defined as follows:
  • Heart failure with subnormal LVEF or clinical fluid overload.
  • Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured).
  • Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) >5 x ULN.
  • Hypoxemia requiring oxygen therapy
• NO acute graft versus host disease (any grade).
• Neutrophil engraftment.