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

November 17, 2008 updated by: PETHEMA Foundation

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alzira, Spain
        • Hospital de la Ribera
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Cadiz, Spain
        • Hospital Puerta del Mar
      • Jerez de la Frontera, Spain
        • Hospital del SAS
      • Leon, Spain
        • Hospital de Leon
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Murcia, Spain
        • Hospital Morales Messeguer
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Salamanca, Spain
        • Hospital Clínico de Salamanca
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valencia, Spain
        • Hospital Universitario la Fe
      • Valencia, Spain
        • Hospital Dr. Pesset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Sanz Guillermo, Dr, Hospital La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (ESTIMATE)

June 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2008

Last Update Submitted That Met QC Criteria

November 17, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD_FLAG-IDA_98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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