Treatment for acute myeloid leukemia (AML) during its first complete remision with the monoclonal antibody Mylotarg ® (anti-CD33/calicheamicina) pre- and post- autologous transplant of hematopoietic stem cells
- Conditions
- Acute myeloid leukemia (AML) during its first complete remision and with high relapse risk, pre- and post- autologous hematopoiteic transplant
- Registration Number
- EUCTR2005-000640-91-ES
- Lead Sponsor
- Institut de Recerca Hospital Sta. Creu i St. Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
- Primary or novo patients with acute myeloid leukemia (AML) different thant M3 subtype or acute promyelocytic myeloid leukemia.
- Age > 18 and < 60 years
- ECOG PS < 3
- Patients with complete remision after induction and intensification chemotherapy , without extramedular affectation.
- Patients would received induction and intensification treatment according to the detailed summary (7. A. 1)
- Expression of CD33 by flow cytometri for at least a 20% of the total.
- Absence of the HLA-identic sibs
- The patient must be recovered from any grade III/IV toxicity of previous chemotherapy treatment (except alopecia).
- Consent informed given
- Patient must have at least one of the following high risk relapse factors:
•cytogenetic alterations, except those that indicate prognosis favourable [t(8;21), inv(16), t(16;16)].
•Normal Cariotype in less that 20 metaphases, or absence of mitosis at diagnosis.
•Presence of internal tandem duplication for the FLT3 gen, at diagnosis or at any time during the follow-up
•Two induction cycles for reaching the first complete remision
•Presence of minimum residual disease (MRD) detectable through CMF (higher than 0,1% of the bone marrow nucleade cells), conventional cariotypeo, FISH or RCP after the intensification detailed in 7.A.1.2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 < 3 months
- Pregnancy or Lactation at the inclusion in the study.
- Creatinine > 2 mg/dl o bilirrubine > 2 mg/dl, or ALT o AST < 2 x UNL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- To evaluate the Mylotarg effect about its ability for mobilizing the hematopoitec stem cells from periferic blood and about the post-transplante hematopoietic recovery<br>- 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)
- Secondary Outcome Measures
Name Time Method