Trials / Completed
CompletedNCT01392989
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Everett Meyer · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Primary Objectives: To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells. Secondary Objectives: * To determine the 2 year overall survival (OS) and event free survival (EFS) * To determine the incidence of acute GVHD following infusion of allogeneic CIK cells * To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.
Conditions
- Neural Tube Defects
- Anemia
- Leukemia, Myeloid
- Bone Marrow Transplant Failure
- Myelodysplastic Syndromes (MDS)
- Myeloproliferative Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CIK cells | Standard of care |
| DRUG | Cyclosporine | 5 mg/kg, po |
| DRUG | Mycophenolate Mofetil | 15 mg/kg, oral |
| DRUG | Thymoglobulin | 7.5 mg/kg, IV |
| RADIATION | Total Lymphoid Irradiation (TLI) |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2016-06-07
- Completion
- 2017-03-19
- First posted
- 2011-07-13
- Last updated
- 2019-05-07
- Results posted
- 2019-05-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01392989. Inclusion in this directory is not an endorsement.