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Sponsors and Collaborators: |
Singapore General Hospital National Medical Research Council |
---|---|
Information provided by: | Singapore General Hospital |
ClinicalTrials.gov Identifier: | NCT00394381 |
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)
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia Myelodysplastic Syndrome, High Grade |
Procedure: Infusion of autologous CIK cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Autologous Cytokine-Induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome |
Estimated Enrollment: | 30 |
Study Start Date: | October 2006 |
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 :
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
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yeh-Ching Linn, MBBS, MRCP | (65) 62223322 ext 6608 | linn.yeh.ching@sgh.com.sg |
Contact: Mickey Koh, MBBS, MRCP, PhD | (65) 62130602 | mickey_koh@hsa.gov.sg |
Singapore | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Contact: Yeh-Ching Linn, MBBS, MRCP (65) 62223322 ext 6608 linn.yeh.ching@sgh.com.sg | |
Contact: Mickey Koh, MBBS, MRCP, PhD (65) 62130602 Mickey_koh@hsa.gov.sg | |
Sub-Investigator: Yeow Tee Goh, MBBS, M.Med | |
Sub-Investigator: William Hwang, MBBS, MRCP, M Med |
Principal Investigator: | Yeh-Ching Linn, MBBS, MRCP | Singapore General Hospital |
Study ID Numbers: | CIK#1/2006 |
Study First Received: | October 31, 2006 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00394381 |
Health Authority: | Singapore: Health Sciences Authority |
acute myeloid leukemia myelodysplastic syndrome autologous CIK cells autologous peripheral blood stem cell transplant |
Myelodysplastic syndromes Leukemia Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplasia |
Myelodysplastic Syndromes Acute myelogenous leukemia Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |