Clinical trial · Interventional
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
NCT00394381CI-TRIAL-00025904completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome, High Grade | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of autologous CIK cells | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CIK infusion
- description
- Infusion of autologous CIK cells in study group. There is only one arm to this study
- interventionNames
- Procedure: Infusion of autologous CIK cells
Primary outcomes (4)
- measure
- blood count changes
- timeFrame
- three months
- measure
- T lymphocyte subsets
- timeFrame
- three months
- measure
- T cell functions
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant. 2. For Group 2: High grade MDS ( RAEB or RAEBIT ) or AML, whom the haematologist in charge has assessed and deemed unfit for chemotherapy with curative intent.Patients must have fairly stable white cell count requiring only low dose or no myelosuppressive medication 3. Patients must understand the trial nature of this treatment and accept the possible absence of benefit. Exclusion Criteria: 1. uncontrolled infection 2. life expectancy less than 6 weeks. 3. Contraindication to undergo one session of leukapheresis for PBMNC harvesting
References
Publications (4)
- BACKGROUNDLinn YC, Lau LC, Hui KM. Generation of cytokine-induced killer cells from leukaemic samples with in vitro cytotoxicity against autologous and allogeneic leukaemic blasts. Br J Haematol. 2002 Jan;116(1):78-86. doi: 10.1046/j.1365-2141.2002.03247.x. PMID 11841399
- BACKGROUNDLeemhuis T, Wells S, Scheffold C, Edinger M, Negrin RS. A phase I trial of autologous cytokine-induced killer cells for the treatment of relapsed Hodgkin disease and non-Hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Mar;11(3):181-7. doi: 10.1016/j.bbmt.2004.11.019. PMID 15744236
- BACKGROUNDSchmidt-Wolf IG, Finke S, Trojaneck B, Denkena A, Lefterova P, Schwella N, Heuft HG, Prange G, Korte M, Takeya M, Dorbic T, Neubauer A, Wittig B, Huhn D. Phase I clinical study applying autologous immunological effector cells transfected with the interleukin-2 gene in patients with metastatic renal cancer, colorectal cancer and lymphoma. Br J Cancer. 1999 Nov;81(6):1009-16. doi: 10.1038/sj.bjc.6690800. PMID 10576658
- BACKGROUNDJiang H, Liu KY, Tong CR, Jiang B, Lu DP. [The efficacy of chemotherapy in combination with auto-cytokine-induced killer cells in acute leukemia]. Zhonghua Nei Ke Za Zhi. 2005 Mar;44(3):198-201. Chinese. PMID 15840260