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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487448
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : November 19, 2008
Information provided by:
PETHEMA Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Acute Myeloblastic Leukemia Drug: Fludarabine Drug: Cytarabine Drug: G-CSF Drug: Idarubicin Procedure: Peripheral blood stem cell transplantation Procedure: Bone marrow transplantation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 1998
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Evaluation of neutropenia and thrombocytopenia duration post-induction chemotherapy [ Time Frame: 3 months ]
  2. Determinate the percentage of patients that reach the transplantation [ Time Frame: 3 months ]
  3. Determinate the toxicity of induction regimen and the chemotherapy postremission [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487448

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Hospital de la Ribera
Alzira, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Spain
Hospital del SAS
Jerez de la Frontera, Spain
Hospital de Leon
Leon, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Dr. Pesset
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
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Study Chair: Sanz Guillermo, Dr Hospital La Fe
Principal Investigator: Sanz Miguel Angel, Dr Hospital La Fe

Additional Information:
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Responsible Party: Dr Josep Mª Ribera. Executive Secretary Identifier: NCT00487448     History of Changes
Other Study ID Numbers: SMD_FLAG-IDA_98
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Peripheral blood stem cells transplantation
Bone marrow transplantation
Secondary Acute Myeloblastic Leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors