Acute Myeloid LeukemiaPhase 2/3AML2001NCT01015196
Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation
A Phase 2/3 study testing Zavedos and Cerubidine in people with Acute Myeloid Leukemia, run by Nantes University Hospital at 1 site in France.
Trial summary
First randomization: After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT) Second randomization: After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Zavedos and Cerubidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to not given
- Phase
- Phase 2/3
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 15 to 60 years
- Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according to WHO classification
- Signed informed consent required
Who cannot join
- AML3 subtype
- Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of MDS
- Isolated extramedullary disease
- Inadequate performance status (≥ 3), cardiac function (LVEF < 40%, severe arythmia or unstable coronary disease), renal function (creatininine > 150 µmol/l), liver functional tests (bilirubin > 35 µmol/l, liver enzymes > 4 times normal values); life expectancy < 3 months
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique
First randomization:
After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT)
Read more
Second randomization:
After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required for all patients
Patients with HLA-identical sibling:
Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR; received 2 more courses of intensive consolidation chemotherapy All others patients received an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative conditioning regimen For patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Zavedos, Cerubidine
- Keywords
- acute myeloid leukemia in first complete remission
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZavedosDrug
CerubidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Idarubicine | Active comparator | Not described Receives: Drug: Zavedos |
| Daunorubicine | Experimental | Not described Receives: Drug: Cerubidine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015196
- Sponsor's protocol ID
- BRD 99/10-L
- Acronym
- AML2001
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bertoli S, Bories P, Bene MC, Daliphard S, Lioure B, Pigneux A, Vey N, Delaunay J, Leymarie V, Luquet I, Blanchet O, Cornillet-Lefebvre P, Hunault M, Bouscary D, Fegueux N, Guardiola P, Dreyfus F, Harousseau JL, Cahn JY, Ifrah N, Recher C; Groupe Ouest-Est d'Etude des Leucemies Aigues et Autres Maladies du Sang (GOELAMS). Prognostic impact of day 15 blast clearance in risk-adapted remission induction chemotherapy for younger patients with acute myeloid leukemia: long-term results of the multicenter prospective LAM-2001 trial by the GOELAMS study group. Haematologica. 2014 Jan;99(1):46-53. doi: 10.3324/haematol.2013.091819. Epub 2013 Aug 23.
PubMed 23975179Guieze R, Cornillet-Lefebvre P, Lioure B, Blanchet O, Pigneux A, Recher C, Bonmati C, Fegueux N, Bulabois CE, Bouscary D, Vey N, Delain M, Turlure P, Himberlin C, Harousseau JL, Dreyfus F, Bene MC, Ifrah N, Chevallier P; GOELAMS. Role of autologous hematopoietic stem cell transplantation according to the NPM1/FLT3-ITD molecular status for cytogenetically normal AML patients: a GOELAMS study. Am J Hematol. 2012 Dec;87(12):1052-6. doi: 10.1002/ajh.23311. Epub 2012 Aug 22.
PubMed 22911473Lioure B, Bene MC, Pigneux A, Huynh A, Chevallier P, Fegueux N, Blaise D, Witz B, Delain M, Cornillon J, Luquet I, Blanchet O, Cornillet-Lefebvre P, Carre M, Hunault M, Larosa F, Lamy T, Randriamalala E, Ojeda-Uribe M, Berthou C, Fornecker L, Harousseau JL, Bouscary D, Ifrah N, Cahn JY; GOELAMS. Early matched sibling hematopoietic cell transplantation for adult AML in first remission using an age-adapted strategy: long-term results of a prospective GOELAMS study. Blood. 2012 Mar 22;119(12):2943-8. doi: 10.1182/blood-2011-05-352989. Epub 2012 Feb 9.
PubMed 22323482
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique
- ClinicalTrials.gov ID
- NCT01015196
- Acronym / sponsor ID
- AML2001 / BRD 99/10-L
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia in first complete remission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2001
- First posted
- 18 Nov 2009 (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.
First randomization:
After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT)
Second randomization:
After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required for all patients
Patients with HLA-identical sibling:
Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR; received 2 more courses of intensive consolidation chemotherapy All others patients received an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative conditioning regimen For patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idarubicine | Active comparator | Drug: Zavedos |
| Daunorubicine | Experimental | Drug: Cerubidine |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 15 to 60 years
- Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according to WHO classification
- Signed informed consent required
Key exclusion criteria (5 listed)
- AML3 subtype
- Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of MDS
- Isolated extramedullary disease
- Inadequate performance status (≥ 3), cardiac function (LVEF < 40%, severe arythmia or unstable coronary disease), renal function (creatininine > 150 µmol/l), liver functional tests (bilirubin > 35 µmol/l, liver enzymes > 4 times normal values); life expectancy < 3 months
- Informed consent refusal
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 |
|---|---|---|
| Zavedos | Drug | Idarubicine |
| Cerubidine | Drug | Daunorubicine |
Primary outcome
Not reported in the source record.
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 18 Nov 2009.
- Derived from this study: PubMed 23975179Bertoli S, Bories P, Bene MC, Daliphard S, Lioure B, Pigneux A, Vey N, Delaunay J, Leymarie V, Luquet I, Blanchet O, Cornillet-Lefebvre P, Hunault M, Bouscary D, Fegueux N, Guardiola P, Dreyfus F, Harousseau JL, Cahn JY, Ifrah N, Recher C; Groupe Ouest-Est d'Etude des Leucemies Aigues et Autres Maladies du Sang (GOELAMS). Prognostic impact of day 15 blast clearance in risk-adapted remission induction chemotherapy for younger patients with acute myeloid leukemia: long-term results of the multicenter prospective LAM-2001 trial by the GOELAMS study group. Haematologica. 2014 Jan;99(1):46-53. doi: 10.3324/haematol.2013.091819. Epub 2013 Aug 23.
- Derived from this study: PubMed 22911473Guieze R, Cornillet-Lefebvre P, Lioure B, Blanchet O, Pigneux A, Recher C, Bonmati C, Fegueux N, Bulabois CE, Bouscary D, Vey N, Delain M, Turlure P, Himberlin C, Harousseau JL, Dreyfus F, Bene MC, Ifrah N, Chevallier P; GOELAMS. Role of autologous hematopoietic stem cell transplantation according to the NPM1/FLT3-ITD molecular status for cytogenetically normal AML patients: a GOELAMS study. Am J Hematol. 2012 Dec;87(12):1052-6. doi: 10.1002/ajh.23311. Epub 2012 Aug 22.
- Derived from this study: PubMed 22323482Lioure B, Bene MC, Pigneux A, Huynh A, Chevallier P, Fegueux N, Blaise D, Witz B, Delain M, Cornillon J, Luquet I, Blanchet O, Cornillet-Lefebvre P, Carre M, Hunault M, Larosa F, Lamy T, Randriamalala E, Ojeda-Uribe M, Berthou C, Fornecker L, Harousseau JL, Bouscary D, Ifrah N, Cahn JY; GOELAMS. Early matched sibling hematopoietic cell transplantation for adult AML in first remission using an age-adapted strategy: long-term results of a prospective GOELAMS study. Blood. 2012 Mar 22;119(12):2943-8. doi: 10.1182/blood-2011-05-352989. Epub 2012 Feb 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zavedos and Cerubidine in people with Acute Myeloid Leukemia, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 5 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 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015196, which also lists 3 linked publications.
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 18 Nov 2009.