NCT02084563

Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Myeloproliferative Neoplasms
• Myelodysplastic Syndromes
• Myeloproliferative/Myelodysplastic Neoplasm

Interventions

Type	Name	Description
DRUG	Induction Chemotherapy	Induction chemotherapy for patients with AML eligible for intensive chemotherapy: * Cytarabine 200 mg/m2 IV continuous infusion days 1-7 * Daunorubicin 90 mg/m2 intravenous piggyback days 1-3
DRUG	Consolidation Chemotherapy	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
DRUG	Autologous Stem Cell Transplantation	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: * Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4 * Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2
DRUG	Allogeneic Stem Cell Transplantation	Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML Conditioning regimen: * Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4 * Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2 or Fludarabine 40 mg/m2 IV once daily days -7 to -4
DRUG	Low Dose Cytarabine	Chemotherapy for patients with AML who are not fit for intensive chemotherapy: * Cytarabine 60 mg/m2 subcutaneous (SQ) bid days 1-5 (until CR or maximum 4 cycles) * Cytarabine 40 mg/m2 SQ bid days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)
DRUG	Decitabine	Chemotherapy for patients with AML who are not fit for intensive chemotherapy: * Decitabine 20 mg/m2 IV once daily days 1-10 (until CR or maximum 4 cycles) * Decitabine 20 mg/m2 IV once daily days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-12-01
• Completion: 2016-11-01
• First posted: 2014-03-12
• Last updated: 2016-11-08

Locations

1 site across 1 country: Brazil