Phase 2
N=44
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
Neural Tube Defects · Anemia · Leukemia, Myeloid · Bone Marrow Transplant Failure · Myelodysplastic Syndromes (MDS)
Bottom Line
View on ClinicalTrials.gov: NCT01392989 ↗Enrolled (actual)
44
Serious AEs
61.4%
Results posted
May 2019
Primary outcome: Primary: Full Donor Chimerism (FDC) — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CIK cells (Drug); Cyclosporine (Drug); Mycophenolate Mofetil (Drug); Thymoglobulin (Drug); Total Lymphoid Irradiation (TLI) (Radiation)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Everett Meyer
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Donor Chimerism (FDC) |
6 | — |
| SECONDARY Overall Survival (OS) |
16 | — |
| SECONDARY Event-free Survival (EFS) Rate |
14; 4 | — |
| SECONDARY Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year |
9; 11; 3; 5; 6; 6 | — |
| SECONDARY Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands |
— | — |
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.
Eligibility Criteria
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 50 years, or 5 years ago without evidence of disease, or 5 years are eligible (prior malignancy is not a requirement)
INCLUSION CRITERIA, DONOR
- Donors must be HLA-matched or one allele mismatched.
- Donor age 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
Data sourced from ClinicalTrials.gov (NCT01392989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.