Status:
COMPLETED
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 myelodys...
Detailed Description
PRIMARY OBJECTIVES: I. Demonstrate that differentiation therapy with DNMT1 depleting but non-DNA damaging doses of decitabine is efficacious and can be administered weekly for \> = 12 months. SECONDA...
Eligibility Criteria
Inclusion
- 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 \< 100 x 10\^9/L OR transfusion dependence for red-cells OR transfusion dependence for platelets OR absolute neutrophil count \< 1 x 10\^9/L
- Exclusion
- MDS of the WHO sub-types RA or RCMD with sole 5q- abnormality on cytogenetics unless failed lenalidomide (Revlimid) therapy
- Previous treatment with decitabine
- Untreated erythropoietin deficiency defined as an erythropoietin level of \< 200 IU/L and erythropoietin replacement therapy for \< 8 weeks (erythropoietin deficiency until corrected)
- Uncontrolled infection
- Severe sepsis or septic shock
- Current pregnancy or breast feeding
- The patient is of childbearing age, and is unwilling to use contraception and has not had a tubal ligation, hysterectomy, or vasectomy , or their partner is also unwilling to use an acceptable method of contraception as determined by the investigator
- Not able to give informed consent
- Altered mental status or seizure disorder
- ALT \> 300 IU; or albumin \< 2.0 mg/dL
- Creatinine \> 2.5 mg/dl and creatinine clearance \< 60ml/min
- B12, folate, or iron deficient, until corrected
- NYHA class III/IV status
- ECOG performance status \> 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
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01165996
Start Date
July 1 2010
End Date
August 1 2012
Last Update
March 4 2019
Active Locations (2)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195