SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Association group of therapeutic specialities authorized in a remission induction treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an intensive postremission treatment with authorized therapeutic association specialities and with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Cytarabine; Fludarabine; Idarubicin

Criteria

Inclusion Criteria:

• Age < 75 years

• Diagnosis of Myelodysplastic Syndrome in order to FAB criteria, excluding patients with chronic myeloid leukemia.

• IPI > 1 (High risk or Intermedia risk-2) and/or IPE equal or > 3 (High risk o Intermedia risk) or secondary acute myeloid leukemia.

• Resolved toxicity for previous treatments received to Myelodysplastic Syndrome .

• Myelodysplastic Syndrome de novo.

Exclusion Criteria:

• Associated neoplasia.

• Chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).

• Age < 55 years with related donor HLA compatible.

• Use an investigational drug in the 30 previous days.

• Previous treatment with chemotherapy agents.

• Simultaneous treatment during the study with other drugs not allowed in the protocol.

• Bilirubin > 2 mg/dL and GPT >2 times the normal value.

• Creatinine > 2 mg/dL.

• Hypersensibility to agents used in the protocol.

• Secondary MDS to chemo-radiotherapy .

• HIV positive.

• Chronic myeloblastic leukemia