Testing ECT-001-CB for high risk acute leukemia

Inclusion

• +i. Karnofsky score ≥ 70% ii. Hematopoietic comorbidity index (HCT-CIConfidence intervalA range showing how precisely a result has been pinned down.Read more →): 0-3 for 2nd transplant and age 60-65 years, 0-5 if \<60 years old, and 0-2 if 66-67 years.
• +Female patients of childbearing potential must have a negative serum pregnancy test within 30 days of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → and within 30 days of starting of preparative regimen; patient must be willing to use an effective contraceptive method while enrolled in the study.
• +Subjects ≥ 18 and ≤ 67 years old,
• +Patient with either i. High risk acute leukemia or myelodysplasia defined as expected 2 year OS or PFS \< 40% after a conventional allogeneic HSC transplant or ii. A hematologic malignancy requiring an allogeneic hematopoietic stem cell transplant and lack of a suitable HLA identical, haploidentical or 7/8 HLA matched donor.
• +Availability of an adequate CB for expansion:
• +i. ≥ 5/8 HLA match when A, B, C and DRB1 are performed at the allele level.
• +ii. Minimal cell dose: TNC ≥ 1.5 x 107/kg, and CD34 ≥ 0.5 x 105/kg. iii. Needs to be erythrodepleted by bank prior to cryopreservation. iv. Must comply with local siteTrial siteA hospital or clinic where a study is actually run.Read more → regulations AND, come from a cord bank that is FACT, or AABB accredited, or FDA approved or eligible for NMDP IND (unless PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → approves another bank).
• +v. To meet eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →, the patient's weight at time of cord selection will be used; however, if this weight has increased by more than 5% at time of admission to hospital and with the new weight the patient no longer meets eligibility criteria for cell dose, LI approval will be required to move forward with the selected cord. Every attempt will be made to always use the most recent weight in cord selection
• +Patients with adequate physical function as measured by:
• +iii. Adequate cardiac function: Left ventricular ejection fraction ≥ 40% within 60 days prior to start of conditioning regimen iv. Adequate pulmonary function: Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted within 60 days prior to start of conditioning regimen.
• +v. Adequate hepatic function: Bilirubin \< 2 x ULN unless felt to be related to Gilbert's disease or hemolysis; AST and ALT ≤ 2.5 x ULN (the PI may approve up to 3 times ULN) ; alkaline phosphatase ≤ 5 x ULN.
• +vi. Adequate renal function: Estimated or measured creatinine clearance ≥ 60 ml/min/1.73m2.
• +A back up graft must have been identified prior to initiation of conditioning regimen.
• +Signed written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.