Allogeneic Cytokine-induced Killer Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies (alloCIK)
Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in patients undergoing mobilization for autologous transplant.
Donor lymphocyte infusion (DLI) has been shown to be active against some haematological malignancies including CML, AML, MDS,NHL and Hodgkin's disease. These donor lymphocytes can be further activated in vitro to become CIK cells. At least 2 other centers in the world have given allogeneic CIK cells for patients relapsing post allogeneic transplant for a variety of haematological malignancies. These early reports have demonstrated feasibility, absence of increased GVHD and possible efficacy in some cases.
We are proposing a Phase I /II study on the feasibility / efficacy of immunotherapy with allogeneic CIK cells for patients who relapse after allogeneic marrow transplant for their haematological malignancies. These patients have to be either refractory to conventional donor lymphocyte infusion, or need a larger number of donor lymphocyte than could be provided by unmanipulated donor lymphocytes. Donor lymphocytes will be collected and cultured in GMP facilities to maturity, then infused into patients. This will be given in graded doses at 4 weekly intervals and continued on in the absence of GVHD till remission is achieved or disease progression occurs. Patients may receive various forms of chemotherapy appropriate to the clinical condition in each case before the allogeneic CIK infusion.
Efficacy will be assessed by comparing the response to allogeneic CIK infusion vs that to due to conventional DLI, ie response to the two different treatment using DLI response as the comparator. We expect about 10 such cases to be done over the next 3 years. Significant statistics is unlikely to be generated but observation and description of the response can generate useful information for presence or not of the efficacy of such a treatment.
If clinical efficacy and superiority over conventional DLI is demonstrated, then future allogeneic CIK may take the place of DLI in this group of poor prognosis patients who relapse after allogeneic transplant .
|Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Non Hodgkin's Lymphoma Hodgkin's Disease Myelodysplastic Syndrome Multiple Myeloma||Biological: infusion of allogeneic CIK cells||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Trial on Allogeneic Cytokine-induced Killer Cell Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies|
- Feasibility of expansion of frozen donor mononuclear cells into CIK [ Time Frame: 2 year ]
- Toxicity including GVHD and marrow aplasia [ Time Frame: 1 year from infusion for each patient ]
- Efficacy in terms of disease response as compared to previous treatment modality ie unmanipulated DLI [ Time Frame: 2 years from infusion for each patient ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Biological: infusion of allogeneic CIK cells
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460694
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Yeh-Ching Linn, MBBS, MRCP||Singapore General Hospital|