Trial Information

FLAG-IDA Chemotherapy Induction Follow by Intensive Chemotherapy Postremission +/- Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.

To reach the first remission, the patients receive one cycle of FLAG-IDA combination, that
include: Fludarabine 30 mg/m 2 /d Days 1 to 4 in IV perfusion during 30 minutes; Cytarabine
2 g/m 2/d, days 1 to 4 in IV perfusion during 4 hours glycosylate G-CSF 300 µg/m 2/d, days
-1 to 5 SC; lenograstim 263 µg/d f, days 11 until absolute neutrophil count >1x10 9 /L SC;
Idarubicin 10 mg/m2/d, days 1 to 3 IV bolus (15 minutes)

Patients who don't reach complete remission (CR) are considered as a failure and must go out
of study.

The participating centres should decide if the patients under 35 years in CR and with
unrelated donor, are excluded to be treated with allogenic transplantation or they continue
in the study.

The patients who reach CR will receive one consolidation cycle with IDA-ARAC + G-CSF
combination:

Idarubicin 10 mg/m2/d, days 1 to 3 IV bolus (15 minutes); Cytarabine 200 mg/m 2/d days 1 to
5 IV in 24 hours continuous perfusion; glycosylate G-CSF(lenograstim) 263 µg, days 12 until
absolute neutrophil count >1x10 9 /L SC

The patients younger than 65 years that is possible, will done an autologous transplantation
with peripheral stem blood cells or combined with peripheral stem blood cells and bone
marrow stem cells. The preparative regimen recommended are BuCy2 (busulfan-cyclophosphamide)
and ICT-Cy (irradiation corporal total-cyclophosphamide).

The patients older than 65 years will receive one intensification cycle with carboplatin and
G-CSF.

The peripheral blood stem cells collection should be done during the recuperation period
after consolidation chemotherapy in patients under 65 years. The leucapheresis procedure
could be determinate for in each center participating.

The patients with no sufficient collection of stem cells during the regeneration period
post-chemotherapy of consolidation, will receive glycosylate G-CSF (lenograstim,
Granocyte®)10 µg/kg/d SC during 5 days, doing the collection cells on days 5 and 6. In the
situations that the peripheral blood stem cells are non satisfactory, will realize a
collection of bone marrow stem cells.

The realization of Peripheral Blood Stem Cell Transplantation or combined, depends the
number of cells obtained in the collection procedures.In the situations that didn't reach
sufficient number of cells (peripheral blood and bone marrow), should be administered one
chemotherapy intensification cycle.

The preparative regimen is established by each participating center, but is recommended one
of next:

1. BuCy2 (busulfan 16 mg/kg follow by cyclophosphamide 120 mg/kg),

2. Total-body irradiation 12 Gy and cyclophosphamide 120 mg/kg.

Intensification treatment:

Patients older than 65 years and younger than 65 who the collection cells for
transplantation is not enough, will receive one cycle of intensification chemotherapy with
carboplatin and glycosylate G-CSF:

Carboplatin 300 mg/m2/d days 1 to 4 IV in 24 hours continuous perfusion glycosylate G-CSF
(lenograstim)263 µg f days 11 until absolute neutrophil count >1x10 9 /L, SC