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

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00487448
First received: June 15, 2007
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

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

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

Estimated Enrollment: 200
Study Start Date: July 1998
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487448

Locations
Spain
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 Universitario La Paz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital Dr. Pesset
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Sanz Guillermo, Dr Hospital La Fe
Principal Investigator: Sanz Miguel Angel, Dr Hospital La Fe
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Josep Mª Ribera. Executive Secretary
ClinicalTrials.gov Identifier: NCT00487448     History of Changes
Other Study ID Numbers: SMD_FLAG-IDA_98
Study First Received: June 15, 2007
Last Updated: November 17, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Chemotherapy
Peripheral blood stem cells transplantation
Bone marrow transplantation
Secondary Acute Myeloblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Fludarabine phosphate
Fludarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014