Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Treatments: Azacitidine; Cytarabine; Daunorubicin; Decitabine

Criteria

Acute Myeloid Leukemia-Intensive Chemotherapy

Inclusion Criteria:

• Diagnosis of AML according to WHO criteria

• Age greater than 18 years

• Performance status (ECOG) between 0-2

• Adequate liver and kidney function

• Signed Informed Consent form

• No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts

• Adequate contraception for fertile men and women

• Eligible for intensive chemotherapy (as judged by the treating physician)

Exclusion Criteria:

• Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)

• Pregnant women

• HIV-positivity

• New York Heart Association class III and IV congestive heart failure

• Patient refuses to use adequate contraception

• History of hypersensibility to any of the used chemotherapy drugs

• Patient refuses to sign informed consent form

Acute Myeloid Leukemia-Non-Intensive Chemotherapy

Inclusion Criteria:

• Diagnosis of AML according to WHO criteria

• Age greater than 18 years

• Signed Informed Consent form

• No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts

• Adequate contraception for fertile men and women

• Non-eligible for intensive chemotherapy (as judged by the treating physician)

Exclusion Criteria:

• Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)

• Pregnant women

• HIV-positivity

• Patient refuses to use adequate contraception

• History of hypersensibility to any of the used chemotherapy drugs

• Patient refuses to sign informed consent form

Chronic Myeloid Disorders:

Inclusion Criteria:

• Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria

• Age greater than 18 years

• Signed Informed Consent form

Exclusion Criteria:

• Patient refuses to sign informed consent form