NCT00394381

Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS) 1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT. 2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable

Detailed description

This is a Phase I /II study on the feasibility / efficacy of adoptive immunotherapy with autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS : 1. Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and 2. Group 2 patients with untreated high grade MDS or AML, who are not fit for standard curative intent chemotherapy. The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities. Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion. Efficacy will be assessed by 1. Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy (n=20 over 3 years), and 2. Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy (n=10).

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome, High Grade

Interventions

Type	Name	Description
PROCEDURE	Infusion of autologous CIK cells	Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2006-11-01
• Last updated: 2017-02-10

Locations

1 site across 1 country: Singapore