Myelodysplastic SyndromePhase 4FLAG-IDANCT00487448
SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia
A Phase 4 study testing Fludarabine, Cytarabine and G-CSF in people with Myelodysplastic Syndrome and Acute Myeloblastic Leukemia, run by PETHEMA Foundation at 15 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloblastic Leukemia
- What is being tested?
- Fludarabine, Cytarabine and G-CSF
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 15 sitesSpain
- Study dates
- Jul 1998to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital de la Ribera
Alzira
Hospital Germans Trias i Pujol
Badalona
Hospital del Mar
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Puerta del Mar
Cadiz
Hospital del SAS
Jerez de la Frontera
Hospital de Leon
León
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
Hospital Morales Messeguer
Murcia
Hospital Central de Asturias
Oviedo
Hospital Clínico de Salamanca
Salamanca
Hospital Arnau de Vilanova
Valencia
Hospital Dr. Pesset
Valencia
Hospital Universitario La Fe
Valencia
About this study
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.
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.
Read the 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:
- BuCy2 (busulfan 16 mg/kg follow by cyclophosphamide 120 mg/kg),
- 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
- Being tested
- Fludarabine, Cytarabine, G-CSF, Idarubicin, Peripheral blood stem cell transplantation
- Keywords
- Myelodysplastic Syndrome, Chemotherapy, Peripheral blood stem cells transplantation, Bone marrow transplantation, Secondary Acute Myeloblastic Leukemia
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
CytarabineDrug
G-CSFDrug
IdarubicinDrug
Peripheral blood stem cell transplantationProcedure or surgery
Bone marrow transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
Measured: 2 years
Secondary outcomes (3)
Evaluation of neutropenia and thrombocytopenia duration post-induction chemotherapy
Measured: 3 months
Determinate the percentage of patients that reach the transplantation
Measured: 3 months
Determinate the toxicity of induction regimen and the chemotherapy postremission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJul 1998
- Primary completionMay 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Sanz Guillermo, Dr, Study chair, Hospital La FeSanz Miguel Angel, Dr, Principal investigator, Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487448
- Sponsor's protocol ID
- SMD_FLAG-IDA_98
- Acronym
- FLAG-IDA
- Status last verified
- Nov 2008
- First submitted
- 15 Jun 2007
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00487448
- Acronym / sponsor ID
- FLAG-IDA / SMD_FLAG-IDA_98
- Keywords
- Myelodysplastic Syndrome, Chemotherapy, Peripheral blood stem cells transplantation, Bone marrow transplantation, Secondary Acute Myeloblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- BuCy2 (busulfan 16 mg/kg follow by cyclophosphamide 120 mg/kg),
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludarabine | Drug | – |
| Cytarabine | Drug | – |
| G-CSF | Drug | – |
| Idarubicin | Drug | – |
| Peripheral blood stem cell transplantation | Procedure or surgery | – |
| Bone marrow transplantation | Procedure or surgery | – |
Primary outcome
Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
Time frame: 2 years
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
- Spanish association of HaematologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanz Guillermo, Dr study chair
Hospital La Fe
Sanz Miguel Angel, Dr principal investigator
Hospital La Fe
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fludarabine, Cytarabine and G-CSF in people with Myelodysplastic Syndrome and Acute Myeloblastic Leukemia, run by PETHEMA Foundation at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008.