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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Patients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate in the efficacy-evaluable (EE) population | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 18 months | |
| Time to AML progression (for MDS and CMML-2 patients only) or death | 18 months | |
| Haematological improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghulam J Mufti, MB, DM, FRCP, FRCPath | Contact | +44 (0) 20 3299 9000 | 3238 | ghulam.mufti@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam J Mufti, MB, DM, FRCP, FRCPath | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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| 18 months |
| Transfusion requirements | 18 months |
| Cytogenetic response | 18 months |
| Treatment related toxicity | Up until one month after last IMP dose |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |