Clinical trial · Interventional
Cytokine Induced Killer (CIK) Cells In Leukemia Patients
Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)Cells After Allogeneic Stem Cell Transplantation
NCT01186809CI-TRIAL-00036710CIK2completedPhase 2Results postedClinicalTrials.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)
The purpose of the Phase IIA study are to: 1. define the safety profile 2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular, cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The progression free survival and the overall survival after the sequential infusion of Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| in vitro expanded Cytokine Induced Killer (CIK) cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytokine Induced Killer
- description
- Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)
- interventionNames
- Biological: in vitro expanded Cytokine Induced Killer (CIK) cells
Primary outcomes (1)
- measure
- Safety Measures
- timeFrame
- Clinical response was measured at 100 days after the completion of the cell therapy program.
- description
- The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale
Secondary outcomes (1)
- measure
- Efficacy Measures
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with a molecular, cytogenetic or haematologic relapse after allogeneic transplantation. * Patients with an available donor willing to donate peripheral blood lymphocytes * Immunosuppression must be withdrawn at the beginning of the cell therapy program * Written informed consent prior to any study procedures being performed Exclusion Criteria: * Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis * Patients with active acute or chronic Graft versus host disease (GvHD) * Patients with rapidly progressive disease or not controlled by palliative supportive treatments including chemotherapy and with a life expectancy less than 8 weeks * Patients with severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study
References
Publications (4)
- RESULTIntrona M, Franceschetti M, Ciocca A, Borleri G, Conti E, Golay J, Rambaldi A. Rapid and massive expansion of cord blood-derived cytokine-induced killer cells: an innovative proposal for the treatment of leukemia relapse after cord blood transplantation. Bone Marrow Transplant. 2006 Nov;38(9):621-7. doi: 10.1038/sj.bmt.1705503. Epub 2006 Sep 18. PMID 16980990
- RESULTIntrona M, Borleri G, Conti E, Franceschetti M, Barbui AM, Broady R, Dander E, Gaipa G, D'Amico G, Biagi E, Parma M, Pogliani EM, Spinelli O, Baronciani D, Grassi A, Golay J, Barbui T, Biondi A, Rambaldi A. Repeated infusions of donor-derived cytokine-induced killer cells in patients relapsing after allogeneic stem cell transplantation: a phase I study. Haematologica. 2007 Jul;92(7):952-9. doi: 10.3324/haematol.11132. PMID 17606446
- RESULTCapelli C, Salvade A, Pedrini O, Barbui V, Gotti E, Borleri G, Cabiati B, Belotti D, Perseghin P, Bellavita P, Biondi A, Biagi E, Rambaldi A, Golay J, Introna M. The washouts of discarded bone marrow collection bags and filters are a very abundant source of hMSCs. Cytotherapy. 2009;11(4):403-13. doi: 10.1080/14653240902960437. PMID 19462317
- RESULTIntrona M, Pievani A, Borleri G, Capelli C, Algarotti A, Mico C, Grassi A, Oldani E, Golay J, Rambaldi A. Feasibility and safety of adoptive immunotherapy with CIK cells after cord blood transplantation. Biol Blood Marrow Transplant. 2010 Nov;16(11):1603-7. doi: 10.1016/j.bbmt.2010.05.015. Epub 2010 Jun 1. PMID 20685246