Clinical trial · Interventional
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or Myeloproliferative Disorders
- 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)
Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Bone Marrow Transplant Failure | — | UNRESOLVED | — |
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Neural Tube Defects | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIK cells | Drug | — | UNRESOLVED |
| Cyclosporine | Drug | — | UNRESOLVED |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Thymoglobulin | Drug | — | UNRESOLVED |
| Total Lymphoid Irradiation (TLI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic Cytokine-induced Killer Cells (CIK)
- description
- Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
- interventionNames
- Drug: CIK cells
- Drug: Cyclosporine
- Drug: Mycophenolate Mofetil
- Drug: Thymoglobulin
- Radiation: Total Lymphoid Irradiation (TLI)
Primary outcomes (1)
- measure
- Full Donor Chimerism (FDC)
- timeFrame
- 90 days
- description
- Proportion of patients achieving full donor T-cell chimerism (FDC) by on or before Day 90 post non-myeloablative allogeneic transplant with allogeneic cytokine-induced killer (CIK) cells will be determined. FDC is defined as the attainment of \>95% donor type CD3+ cells. The outcome will be reported as number of participants who achieved full donor chimerism, a number without dispersion.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
INCLUSION CRITERIA, RECIPIENT WITH MYELODYSPLASTIC SYNDROME (MDS) * Diagnosis of MDS classifiable by the World Health Organization (WHO) on the basis of: * Refractory anemia * Refractory anemia with excess blasts-1 * Refractory anemia with excess blasts-2 * Refractory cytopenia with multi-lineage dysplasia * Refractory cytopenia with multi-lineage dysplasia and ringed sideroblasts * Chronic myelomonocytic leukemia (CMML) * MDS transformed to acute leukemia * MDS-unclassified * Participants with advanced MDS must have \< 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior. * Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts \< 5% INCLUSION CRITERIA, RECIPIENT WITH MYELOPROLIFERATIVE DISORDER (MPD) * Diagnosis of MPD on the basis of: * Idiopathic myelofibrosis * Polycythemia vera * Essential thrombocythemia * Chronic myelomonocytic leukemia (CML) * CML, Philadelphia chromosome-negative * Chronic neutrophilic leukemia * Chronic eosinophilic leukemia * Hypereosinophilic cyndrome * Systemic mastocytosis * \< 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior. * Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts \< 5%. Presence of residual dysplastic features following cytoreductive therapy is acceptable. INCLUSION CRITERIA, RECIPIENT WITH THERAPY-RELATED MYELOID NEOPLASM (t MDS) * \< 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior. * Morphologic leukemia free-state with blasts \< 5 %. * Age \> 50 years, or \< 50 years of age but at high-risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy * Availability of a fully HLA-matched or single antigen/allele mismatched sibling or unrelated donor * Prior malignancy diagnosed \> 5 years ago without evidence of disease, or \< 5 years ago with life expectancy of \> 5 years are eligible (prior malignancy is not a requirement) INCLUSION CRITERIA, DONOR * Donors must be HLA-matched or one allele mismatched. * Donor age \< 75 (EXCEPTION by Principal Investigator discretion) * Must consent to PBSC mobilization with G-CSF; apheresis; and collection and donation of plasma * Donor must consent to placement of a central venous catheter in the event that peripheral venous access is limited. EXCLUSION CRITERIA, RECIPIENT Any of the following: * Uncontrolled CNS involvement with disease * Pregnant * Cardiac function: ejection fraction (EF) \< 35% or uncontrolled cardiac failure * Diffusing capacity of the lungs for carbon monoxide (DLCO) \< 40% predicted * Bilirubin \> 3 mg/dL * Aspartate aminotransferase (AST) \> 3x the upper limit of normal (ULN) * Alanine aminotransferase (ALT) \> 3x ULN * Estimated creatinine clearance \< 50 mL/min * Karnofsky performance score (KPS) \< 70% * Documented fungal disease that is progressive despite treatment * HIV-positive EXCLUSION CRITERIA, DONOR Any of the following: * Identical twin to recipient * Pregnant or lactating * Prior malignancy within the preceding 5 years (EXCEPTION: non-melanoma skin cancers) * HIV seropositivity
References
Publications (1)
- DERIVEDNarayan R, Benjamin JE, Shah O, Tian L, Tate K, Armstrong R, Xie BJ, Lowsky R, Laport G, Negrin RS, Meyer EH. Donor-Derived Cytokine-Induced Killer Cell Infusion as Consolidation after Nonmyeloablative Allogeneic Transplantation for Myeloid Neoplasms. Biol Blood Marrow Transplant. 2019 Jul;25(7):1293-1303. doi: 10.1016/j.bbmt.2019.03.027. Epub 2019 Apr 3. PMID 30951840