Acute myeloid leukemia (AML) during its first complete remision and with high relapse risk, pre- and post- autologous hematopoiteic transplant
Conditions
Interventions
Trade Name: Mylotarg
Product Name: Mylotarg
Pharmaceutical Form: Injection*
INN or Proposed INN: GENTUZUMAB OZOGAMICINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Institut de Recerca Hospital Sta. Creu i St. Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary or novo patients with acute myeloid leukemia (AML) different thant M3 subtype or acute promyelocytic myeloid leukemia. - Age > 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous autologous or alogenic transplant. - Acute lekemia after a 6 months myeloproliferative process or myelodysplastic syndrome, AML that appears after another cured malignant disease (e.g. Hodgkin disease) and AML due to the treatment with alquilant agents or radiations. - Acute promyelocytic leukemia - Complete remision with more than 2 induction cycles - History of relevant hepatic disease, including occlusive hepatic veno disease during the induction or consolidation treatment - Positive serology for HIV, Hepatitis C or hepatitis B surface antigen. - Active infection at the inclusion in the study. - Life expectancy 2 mg/dl o bilirrubine > 2 mg/dl, or ALT o AST < 2 x UNL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of the Mylotarg administration in patients with acute myeloid leukemia (AML) during its first complete remision and with high relapse risk, pre- and post- autologous hematopoiteic transplant;Secondary Objective: - To evaluate the immediately toxicity due to the Mylotarg administration pre- and post- autologous hematopoiteic transplant - To evaluate the Mylotarg effect about its ability for mobilizing the hematopoitec stem cells from periferic blood and about the post-transplante hematopoietic recovery - To evaluate the Mylotarg effect about the minimum residual disease (MRD) post- consolidation chemotherapy and post-transplant, whereas exits markers, analysed by cytogenetic, inmunophenotipic and molecular methods.;Primary end point(s): Leukemia relapse frequencies pre- and post- autologous trasplant of hematopoitec stem cells (historic control) | — |
Countries
Spain
Outcome results
None listed