Phase 2
Completed N=25
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
Chronic myelomonocytic leukemia · de Novo Myelodysplastic Syndromes · Myelodysplastic Syndromes · Refractory Anemia
Source: ClinicalTrials.gov NCT01165996 ↗
Enrolled (actual)
25
Serious AEs
60.0%
Results posted
Feb 2013
Primary outcomePrimary: Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia — 7; 4; 0; 9 participants
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.
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 | — |
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. Informational only — not medical advice.