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| ID | Type | Description | Link |
|---|---|---|---|
| 11/1714 | Other Identifier | HIAE CEP |
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The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.
Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML-Intensive Chemotherapy | Other | Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days. Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk:
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| AML-Non-intensive chemotherapy | Other | Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs. Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory. |
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| Chronic Myeloid Disorders | No Intervention | Patients with Chronic Myeloid Disorders:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction Chemotherapy | Drug | Induction chemotherapy for patients with AML eligible for intensive chemotherapy:
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of molecular and cytogenetic abnormalities | As assessed by results of molecular and cytogenetic tests and frequency in the population studied | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms | 5 years |
| Response rate |
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Acute Myeloid Leukemia-Intensive Chemotherapy
Inclusion Criteria:
Exclusion Criteria:
Acute Myeloid Leukemia-Non-Intensive Chemotherapy
Inclusion Criteria:
Exclusion Criteria:
Chronic Myeloid Disorders:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio P Santos, MD | Hospital Israelita Albert Einstein | Study Director |
| Nelson Hamerschlak, MD, PhD | Hospital Israelita Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | Sรฃo Paulo | Sรฃo Paulo | 05651901 | Brazil |
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| Consolidation Chemotherapy | Drug | Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors: -Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles |
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| Autologous Stem Cell Transplantation | Drug | Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
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| Allogeneic Stem Cell Transplantation | Drug | Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML Conditioning regimen:
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| Low Dose Cytarabine | Drug | Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
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| Decitabine | Drug | Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
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Evaluate complete remission (CR) rate at 1 month for patients with Acute Myeloid Leukemia who received induction chemotherapy. Complete remission was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L neutrophils and >100x10^9/L platelets in the peripheral blood (PB)
| 1 month |
| Disease Free Survival | Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy | 5 years |
| Cumulative incidence of relapse and non-relapse mortality | Evaluate 5-years cumulative incidence of relapse and non-relapse mortality in patients with Acute Myeloid Leukemia who achieve complete remission following induction chemotherapy | 5 years |
| Number of participants with adverse events as a measure of safety and tolerability | Evaluate hematological and non-hematological toxicity in patients with Acute Myeloid Leukemia treated according to the protocol. Toxicity will be graded as per the National Cancer Institute Common Toxicity Criteria for Adverse Events v4.0.3 | 1 year |
| Cumulative Incidence of Transformation to Acute Myeloid Leukemia | Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms | 5 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009196 | Myeloproliferative Disorders |
| D009190 | Myelodysplastic Syndromes |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D007938 | Leukemia |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D060828 | Induction Chemotherapy |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D060830 | Consolidation Chemotherapy |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D012263 | Ribonucleosides |
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