Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

PHASE2CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

November 30, 2016

Conditions
Acute Myeloid LeukemiaMyeloproliferative NeoplasmsMyelodysplastic SyndromesMyeloproliferative/Myelodysplastic Neoplasm
Interventions
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)"

Trial Locations (1)

05651901

Hospital Israelita Albert Einstein, São Paulo

All Listed Sponsors
lead

Hospital Israelita Albert Einstein

OTHER

NCT02084563 - Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms | Biotech Hunter | Biotech Hunter