| Ad Title: |
Azacitidine with or without Entinostat for the treatment of MDS, CMML and AML |
| Study Title: |
A Randomized Phase II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type) and Acute Myeloid Leukemia with Multilineage Dysplasia |
| Protocol Number: |
122006-037 |
| Department(s) involved in the Study: |
Int Med - Hematology
|
| Purpose of the Study: |
To estimate the overall response rate and toxicity to Azacitidine and Entinostat |
| Participant Eligibility: |
1. Myelodysplastic Syndromes: blast count must be < 20% and patients with any IPSS are eligible. Patients with low or INT-1 IPSS must have a platelet count < 50,000 and/or ANC < 500 within seven days prior to registration.
2. Chronic Myelomonocytic Leukemia (Dysplastic subtype): Must have a WBC < 12,000 documented within 4 weeks prior to study entry
3. Acute Myeloid Leukemia with multilineage dysplasia: Must have > 20% blasts on bone marrow aspirate or biopsy. Includes patients formerly diagnosed with FAB criteria as RAEB-t, as well as patients with no history of antecedent hematologic disorder who have AML which meets criteria for AML-TLD by WHO criteria. Must have WBC < 30,000.
4. No pregnant or breast-feeding women
5. No prior treatment with Azacitidine, decitabine or Entinostat
6. Patients must not have received any AML induction chemotherapy or stem cell transplantation.
7. No clinical evidence of CNS or pulmonary leukostasis or CNS leukemia |
| Disease/Condition Under Study: |
Myelodysplastic syndromes with any IPSS, Chronic Myelomonocytic Leukemia (Dysplastic subtype) and Acute Myeloid Leukemia with multilineage dysplasia |
| Cancer Related Study: |
Yes
|
| Study Drug(s): |
Aidaza, 5-Azacitidine, 5-Azadytidine, 5-AC, 5-AZA (Azacitidine), MS-27-275 (MS-275)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Robert Collins |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
UT Southwestern University Hospitals St. Paul Building
|
No
|
|
UT Southwestern University Hospitals Zale Lipshy Building
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214_648_4155 |
| Email: |
robert.collins@utsouthwestern.edu |
| Other Information: |
|
| Website Keywords: |
Hematology, Oncology
|
| Medical Keywords: |
Acute Myeloid Leukemia, AML, Chronic Myelomonocytic Leukemia, CMML, MDS, Myelodysplastic syndromes
|
