PILOT STUDY PHASE II, Multicenter, Non-randomized, TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN INDUCTION AND POST-INDUCTION IN PATIENTS WITH NOVO Acute Myeloid Leukemia (AML) WITH Cytogenetic Abnormality Monosomy 5
1. Confirm the diagnosis of AML according to WHO criteria (Annex 4).
2. AML de novo (ie, patients without documented history of previous treatment with
antineoplastic agents for radiotherapy or other oncological diseases, hematological
or immunological, related to the development of secondary LMAs and secondary AML
patients without primary MDS with del (5q) or -5 [documented history of primary MDS
with transformation to LMAs]).
3. Diagnostic confirmation of the abnormality del (5q) or -5, with or without other
cytogenetic abnormalities. It is not necessary that the del (5q) including band 5q31.
4. Patients who have received one cycle of induction chemotherapy consisting of a
classical combination of anthracycline and cytarabine (with or without etoposide as a
third agent associated), regardless of the response.
5. Patients have been evaluated the response to induction chemotherapy with
anthracyclines and cytarabine (with or without etoposide as third agent partner) and
were classified according to the criteria of IWG.20
6. ≤ 60 patients ineligible for allogeneic hematopoietic progenitors.
7. Patients> 60 years are not eligible for allogeneic hematopoietic stem cell, or
eligible but did not have HLA-identical brother.
8. Accept the use of any contraceptive method effective in patients of childbearing age
with reproductive potential (see Section 6.5 on pregnancy prevention plan).
9. Ability to understand and voluntarily sign informed consent form.
10. Age ≥ 18 years at the time of signing the informed consent form.
11. Ability and willingness to follow the schedule of study visits.
1. AML secondary to treatment with cytostatic or immunosuppressive agents,
myelodysplastic syndrome or other neoplastic disease.
2. AML with cytogenetic abnormalities t (15, 17), t (8; 21), t (16; 16) or inv (16) or
their associated molecular rearrangements.
3. Patients who have received remission induction with a different regime to cytarabine
anthracycline / - etoposide.
4. ≤ 60 patients eligible for allogeneic hematopoietic progenitors.
5. Patients> 60 years eligible for allogeneic hematopoietic stem cell transplant and who
have HLA-identical brother.
6. Patients who have not been evaluated the response to induction chemotherapy (complete
remission, partial remission or resistance (see Table 6).
7. ECOG 3-4.
8. Any of the following laboratory abnormalities Serum creatinine> 2.0 mg / dl (177 mmol
/ l). serum aspartate aminotransferase (AST) / glutamic oxalacetic transaminase
serum (SGOT) or alanine aminotransferase (ALT) / serum glutamate pyruvate
transaminase (SGPT)> 5.0 x upper limit of normal (ULN).
total serum bilirubin> 3 mg / dl.
9. Patient with known positive HIV serology. No HIV test is required in the process of
10. Any severe psychiatric condition or disease that prevents the patient sign the
informed consent form for the patient or involves an unacceptable risk should
participate in the study.
11. Any serious organic disease or condition that behave for the patient if an
unacceptable risk to participate in the study.
12. Previous use of cytotoxic chemotherapy agents or experimental agents (agents are not
commercially available) for the treatment of AML.
13. Pregnant or breastfeeding (see Section 6.5 on pregnancy prevention plan).