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

NCT00487448 | Completed Phase 4 DMC

• 1 other identifier: SMD_FLAG-IDA_98
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

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.

Conditions

Myelodysplastic Syndrome; Acute Myeloblastic Leukemia

Keywords

Myelodysplastic Syndrome; Chemotherapy; Peripheral blood stem cells transplantation; Bone marrow transplantation; Secondary Acute Myeloblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival

  2 years

Secondary Outcomes (3)

• Evaluation of neutropenia and thrombocytopenia duration post-induction chemotherapy

  3 months

• Determinate the percentage of patients that reach the transplantation

  3 months

• Determinate the toxicity of induction regimen and the chemotherapy postremission

  1 year

Interventions

Fludarabine DRUG

Cytarabine DRUG

G-CSF DRUG

Idarubicin DRUG

Peripheral blood stem cell transplantation PROCEDURE

Bone marrow transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (15)

Hospital de la Ribera

Alzira, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Puerta del Mar

Cadiz, Spain

Location

Hospital del SAS

Jerez de la Frontera, Spain

Location

Hospital de Leon

León, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Morales Messeguer

Murcia, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Dr. Pesset

Valencia, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

fludarabine; Cytarabine; Granulocyte Colony-Stimulating Factor; Idarubicin; Peripheral Blood Stem Cell Transplantation; Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Tissue Transplantation

Study Officials

• Sanz Guillermo, Dr

  Hospital La Fe

  STUDY CHAIR

• Sanz Miguel Angel, Dr

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: July 1, 1998
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

ES (15)