AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3NCT00880243

Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)

A Phase 3 study testing GM-CSF in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is: 1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during induction and consolidation courses versus no priming. 2. To compare as consolidation timed sequential chemotherapy versus four courses of high dose cytarabine. Read more about this study

Who is it for?
Ages 15 to 50 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
GM-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
473 participants
Where
No sites listed yet
Study dates
Mar 1999to Sep 2006
Phase
Phase 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 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • A morphologically proven diagnosis of AML according to the WHO classification
  • Serum creatinine < 2N; AST and ALT < 2.5N; total bilirubin < 2N (unless related to the underlying disease).
  • ECOG performance status 0 to 2.
  • Women of child-bearing must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
  • Must be able and willing to give written informed consent

Who cannot join

  • Patients with M3-AML. Patient with AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).
  • Patient presenting any diagnosis of uncontrolled or metastatic tumor.
  • Patients with uncontrolled severe infection,

About this study

Official title: Effect of Priming With Granulocyte-Macrophage Colony-Stimulating Factor During Chemotherapy and Comparison of Timed Sequential Chemotherapy vs 4 Courses of High Dose Cytarabine as Consolidation in Younger Adults With Newly Diagnosed AML

The purpose of this study is:

  1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during induction and consolidation courses versus no priming.
  2. To compare as consolidation timed sequential chemotherapy versus four courses of high dose cytarabine.
Read the detailed description

Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy consists of a timed-sequential chemotherapy including a first sequence of chemotherapy combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days (days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same period. The second sequence, administered after 4-day free interval, consists of mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and 9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10). Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine, 100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day, intravenously beginning at day 1 of each chemotherapy course and continuing until the last day of chemotherapy of each course.

Patients who achieve CR after induction chemotherapy or salvage therapy are randomly assigned to consolidation courses consisting of either a timed sequential chemotherapy similar to that of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1 arm), which includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance courses.

Being tested
GM-CSF
Keywords
Acute myeloid leukemia, Priming, GM-CSF, Timed-sequential chemotherapy, Prognosis
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.

  • GM-CSFDrug

    Also called GM-CSF: molgramostim, AraC: Cytarabine, Daunorubicine: Cerubidine, EMA: etoposide, mitoxantrone, cytarabine

    Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.

    Randomiization 2: Consolidation high dose AraC versus consolidation EMA

Study groups in NCT00880243
Study groupRoleWhat they receive
EMA+GM-CSFExperimental* Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, * AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, * Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 * AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10. * GM-CSF (LeucomaxR): 5 µg/kg/jour IV over 6 hours from day 1 to day 10.
Receives: Drug: GM-CSF
EMA without GM-CSFActive comparator* Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, * AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, * Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 * AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10.
Receives: Drug: GM-CSF
HD AraC+ GM-CSFExperimental* AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5 * GM-CSF :5 µg/kg/d IV (6 hours) from day1 to day 5
Receives: Drug: GM-CSF
HD-AraC without GM-CSFActive comparator- AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5
Receives: Drug: GM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing the potential value of the daily administration of GM-CSF during induction chemotherapy and post-induction for analyzing and comparing the arms with and without GM-CSF: EFS, % of CR, duration of remission, OS and toxicity of each treatment.

    Measured: 72 months

Secondary outcomes (1)

  1. Evaluate the effectiveness on DFS of a single course of consolidation using a very intensive sequential chemotherapy with mitoxantrone, AraC and etoposide feasible compared to 4 courses of high dose AraC followed of 4 courses of maintenance.

    Measured: 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2009 (estimated)
  2. Study startMar 1999
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880243
Sponsor's protocol ID
ALFA 9802
Status last verified
Apr 2009
First submitted
8 Apr 2009
Last updated
13 Apr 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Thomas X, Raffoux E, Botton Sd, Pautas C, Arnaud P, de Revel T, Reman O, Terre C, Corront B, Gardin C, Le QH, Quesnel B, Cordonnier C, Bourhis JH, Elhamri M, Fenaux P, Preudhomme C, Michallet M, Castaigne S, Dombret H. Effect of priming with granulocyte-macrophage colony-stimulating factor in younger adults with newly diagnosed acute myeloid leukemia: a trial by the Acute Leukemia French Association (ALFA) Group. Leukemia. 2007 Mar;21(3):453-61. doi: 10.1038/sj.leu.2404521. Epub 2007 Jan 25.

    PubMed 17252021

  • Thomas X, Elhamri M, Raffoux E, Renneville A, Pautas C, de Botton S, de Revel T, Reman O, Terre C, Gardin C, Chelghoum Y, Boissel N, Quesnel B, Hicheri Y, Bourhis JH, Fenaux P, Preudhomme C, Michallet M, Castaigne S, Dombret H. Comparison of high-dose cytarabine and timed-sequential chemotherapy as consolidation for younger adults with AML in first remission: the ALFA-9802 study. Blood. 2011 Aug 18;118(7):1754-62. doi: 10.1182/blood-2011-04-349258. Epub 2011 Jun 20.

    PubMed 21690555

  • Boissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.

    PubMed 20625116

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GM-CSF in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association.

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 3 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 13 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

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 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.

What does the primary outcome measure?

Assessing the potential value of the daily administration of GM-CSF during induction chemotherapy and post-induction for analyzing and comparing the arms with and without GM-CSF: EFS, % of CR, duration of remission, OS and toxicity of each treatment. (time frame: 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00880243, 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 13 Apr 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in