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Allogeneic CIK Immunotherapy for Relapsed Haematological Malignancies
NCT00460694Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2006
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Singapore General Hospital
- Modality
- Allogeneic CAR-T, Tumor-Infiltrating Lymphocytes (TILs), TCR-Engineered T Cells
- Drugs
- unmodified CIK
- Conditions
- acute myeloid leukemia (AML)acute lymphoblastic leukemia (ALL)chronic myeloid leukemia (CML)non-Hodgkin lymphoma (NHL)Hodgkin lymphoma (HL)
01
Overview
Phase 2, open-label, single-arm trial of unmodified CIK in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and 4 more, sponsored by Singapore General Hospital. Primary endpoints: Feasibility of expansion of frozen donor mononuclear cells into CIK at 2 years and Toxicity including GVHD and marrow aplasia at 1 year. Started Aug 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Allogeneic CIK cells
Infusion of allogeneic CIK cells at graded doses.
03
Who it enrols
Patients who have relapsed after an allogeneic transplant and are refractory to, intolerant of, or unable to access conventional donor lymphocyte infusion (DLI).
04
Endpoints
Primary
Feasibility of expansion of frozen donor mononuclear cells into CIK
Toxicity including GVHD and marrow aplasia
Secondary
Efficacy in terms of disease response
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