Phase 2
N=25
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia · de Novo Myelodysplastic Syndromes · Myelodysplastic Syndromes · Refractory Anemia · Refractory Anemia With Excess Blasts
Bottom Line
View on ClinicalTrials.gov: NCT01165996 ↗Enrolled (actual)
25
Serious AEs
60.0%
Results posted
Feb 2013
Primary outcome: Primary: Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia — 7; 4; 0; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- flow cytometry (Other); DNA methylation analysis (Other); cytogenetic analysis (Other); decitabine (Drug); microarray analysis (Genetic); gene expression analysis (Genetic); pharmacological study (Other); polymorphism analysis (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia |
7; 4; 0; 9; 5 | — |
| SECONDARY Number of Patients That Experience > Grade 2 Non-hematologic Toxicity by National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) v4 Criteria |
16 | — |
| SECONDARY Cytogenetic Response as Per IWG Criteria |
5; 2; 4 | — |
| SECONDARY Proportion of Patients With Pharmacodynamic Evidence of Drug Effect. |
25 | — |
| SECONDARY Proportion of Patients With Bone Marrow Evidence of Cytotoxicity. |
5; 2 | — |
| SECONDARY Proportion of Patients With Bone Marrow Evidence of Terminal Differentiation Response to Therapy. |
11 | — |
| SECONDARY Proportion of Patients With Particular Genetic Abnormalities Detected by Whole Exome Sequencing Correlation With Clinical Response |
4 | — |
Summary
RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.
Eligibility Criteria
Inclusion
- MDS classified by hematopathology review as WHO categories refractory anemia (RA) or refractory cytopenia with multi-lineage dysplasia (RCMD) or refractory anemia with ring sideroblasts (RARS) or refractory anemia with excess blasts (RAEB1 or RAEB2) or chronic myelo-monocytic leukemia (CMML1 or CMML2)
- Symptomatic anemia OR thrombocytopenia with a platelet count of 300 IU; or albumin 2.5 mg/dl and creatinine clearance 2
- HIV positive or history of seropositivity for HIV
- Transformation to acute leukemia ( >= 20% myelo-blasts in marrow aspirate)
- Any experimental agents other than the study drug decitabine
Data sourced from ClinicalTrials.gov (NCT01165996). 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.