Natural Killer Cells in Acute Leukaemia and Myelodysplastic Syndrome

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · Apr 25, 2014

Keywords

ClinConnect Summary

The study will enroll 20 eligible subjects who will receive NK cell infusion to test whether infusion of expanded activated NK cells can produce measurable clinical responses in patients with AML/MDS or T-ALL.The study aims to infuse a target dose of 10 x 107 CD56+ cells/kg, however, as the actual cell dose obtained will vary depending on the donor harvest, the accepted range for cell infusion will be 0.5-20 x 107 CD56+ cells/kg. On day -10, eligible donors (adult family member of recipient) will undergo apheresis once. A second apheresis procedure may be needed to obtain the required cell ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: (NK cell Recipient)
• • From 6 to 80 years old at time of consent.
• * Patients with the following haematological diseases:
• • Acute myeloid leukaemia (de novo or secondary)
• • Myelodysplastic syndromes (RAEB I/II)
• • T-cell acute lymphoblastic leukaemia (T-ALL)
• • Patients must have been treated with prior standard intensive chemotherapy upfront, which will be defined according to institutional practice for each respective disease, and may include allogeneic haematopoietic stem cell transplantation.
• • Patients must have persistent detectable residual leukaemia following initial treatment with intensive chemotherapy. Residual leukaemia is defined as the presence of \>=0.01%-20% blasts in the bone marrow by flow cytometry.
• • High risk AML patients with either High risk cytogenetics or FLT3-ITD mutation or Acute megakaryoblastic leukaemia in non-Down's Therapy related leukaemia or Myelodysplastic syndrome
• • will qualify for NKEXPSIN either after Induction I chemotherapy or Induction II chemotherapy regardless of residual disease.
• • At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
• • Shortening fraction greater than or equal to 25%.
• • Glomerular filtration rate greater than or equal to 60ml/min.
• • Pulse oximetry greater than or equal to 92% on room air.
• • Direct bilirubin less than or equal to 3x Upper Limit of Normal (ULN).
• • Karnofsky performance score of greater than or equal to 50.
• • Has a suitable adult family member donor available for NK cell donation.
• • Ability to provide informed consent. Otherwise, a legally authorized representative (LAR) must be present throughout the consent process and is allowed to give consent on the patient's behalf.
• • Inclusion Criteria: (NK cell Donor)
• • At least 21 years old at time of consent.
• • A family member with a greater than or equal to 3 of 6 HLA match to recipient
• • Ability to provide informed consent. Otherwise, a legally authorized representative must be present throughout the consent process and is allowed to give consent on the patient's behalf.
• • Exclusion Criteria: (NK cell Recipient)
• • Currently has pleural or pericardial effusion.
• • Receiving more than the equivalent of prednisone 10 mg daily.
• • Lactating or pregnant. Negative serum or urine pregnancy test result must be within 7 days prior to enrolment.
• • Exclusion Criteria: (NK cell Donor)
• • HIV positive. Negative results must be within 60 days prior to enrolment.
• • Lactating or pregnant. Negative serum or urine pregnancy test result must be within 7 days prior to enrolment.