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Acute Myeloid LeukemiaPhase 3FLUGAZANCT02319135

Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine (Fluga Scheme) in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 3 study testing Azacitadine, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 1 site in Spain.

Completed

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

Official record
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Trial summary

The hypothesis is that the replacement of the standard fludarabine and cytarabine based therapy by azacytidine could result in an improvement of RFS and OS rates in the experimental arm. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Azacitadine, Fludarabine and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
289 participants
Where
1 siteSpain
Study dates
Oct 2014to 28 Oct 2019
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • - Having voluntarily given informed consent before performing any test that is not part of
  • routine care of patients.
  • - Age greater than or equal to 65.
  • - Morphological diagnosis of non-promyelocytic AML according to the WHO criteria.
  • - Newly diagnosed AML.
  • - ECOG performance status <4.
  • - Ability and willingness to comply with the schedule of study visits.

Who cannot join

  • - Genetic diagnosis of acute promyelocytic leukemia.
  • - Patients with AML secondary to myelodysplastic syndrome (MDS) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents
  • (hypomethylating or standard chemotherapy). Treatment with hydroxyurea prior to randomization is allowed.
  • - Serum creatinine ≥ 250 mmol / l (≥ 2.5 mg/dL) (unless attributed to AML).
  • - Bilirubin, alkaline phosphatase or ALT > 5 times the value of the upper limit of normal (unless attributed to AML) .
  • - Presence of an active and/or non controlled pathology different to AML which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study.
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  • - Other active concomitant malignancy or whose remission is less than one year from the screening day (except carcinoma in situ).
  • - Presence of any psychiatric illness or medical condition that, in the investigator's opinion, prevents the subject participation in the study.
  • - Life expectancy less than X months.
  • - Inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

About this study

Official title: A PHASE III, MULTICENTRE, RANDOMIZED, OPEN LABEL CLINICAL TRIAL OF AZACYTIDINE (VIDAZA®) VERSUS FLUDARABINE AND CYTARABINE (FLUGA SCHEME) IN ELDERLY PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA.

The hypothesis is that the replacement of the standard fludarabine and cytarabine based therapy by azacytidine could result in an improvement of RFS and OS rates in the experimental arm. To fulfill the medical needs in such frail and elderly population, improvements in terms of atileukemic efficacy in the azacytidine experimental arm should be attained without increasing the therapy-related toxicity or decreasing the patients QoL.

Read the detailed description

This is a multicenter, randomized 1:1, open, and at national level, Phase III clinical trial.

This study will be conducted in 3 phases of different duration:

  1. Selection phase (up to 14 days from the signature of informed consent): informed consent and review of the inclusion and exclusion criteria performing the relevant assessments.
  2. Treatment Phase (from the start of treatment until the end of cycle 9): Induction phase (3 cycles) and consolidation phase (cycles 4-9). Study visits during treatment will be weekly during the induction phase (first 3 cycles) and every 2 weeks until the end of the consolidation phase.
  3. Follow-up phase: monthly monitoring will be performed on all patients until they have completed a minimum of 2 years from the start of treatment, whether or not they continue receiving azacitidine cycles or Mini-Fluga according to the protocol. Following these 24 months, follow-up will be carried out at least quarterly. Patients suffering disease progression or relapse of the disease, or being early withdrawn due to any of the reasons specified in the protocol will be followed-up for survival until the end of the study or until the death of all patients, whichever comes first.
Being tested
Azacitadine, Fludarabine, Cytarabine, Lenograstim, Filgastrim
Keywords
Acute Myeloid Leukemia
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.

Study groups in NCT02319135
Study groupRoleWhat they receive
fludarabine cytarabineActive comparatorPriming with daily administration of subcutaneous G-CSF (lenograstim or filgrastim 5 mcg /kg / day, days -1, 1 and 2) (not given if hyperleukocytosis> 25 x 109/l), followed by: * Oral fludarabine (40 mg/m2/day, days 1 to 5) and subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (FLUGA scheme) (fludarabine and cytarabine only days 1 to 4 if age ≥75 years), OR * Fludarabine (25 mg/m2/day) and cytarabine (75 mg/m2/day infusion of 6 hours) on their intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days
Receives: Drug: Fludarabine; Drug: Cytarabine; Drug: Lenograstim; Drug: Filgastrim
AzacitidineExperimentalSubcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.
Receives: Drug: Azacitadine

What is being measured

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

  1. Efficacy (overall survival (OS) attained without increasing the therapy-related toxicity or decreasing the patients QoL.

    To evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses(Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).

    Measured: 4 years

Secondary outcomes (4)

  1. Efficacy (Event free survival (EFS)

    Event free survival (EFS)

    Measured: 4 years

  2. Efficacy (Duration of remission.)

    Duration of remission.

    Measured: 4 years

  3. Efficacy (Overall survival) Efficcacy

    Overall survival at 2nd and 3rd year.

    Measured: 3 years

  4. Safety (Compare hematologic and non-hematologic toxicity)

    Compare hematologic and non-hematologic toxicity in both arms.

    Measured: 3 years

Timeline

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

  1. First posted18 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion28 Oct 2018
  4. Study completion28 Oct 2019

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
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02319135
Sponsor's protocol ID
FLUGAZA
Acronym
FLUGAZA
Status last verified
Apr 2020
First submitted
10 Dec 2014
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Ayala R, Rapado I, Onecha E, Martinez-Cuadron D, Carreno-Tarragona G, Bergua JM, Vives S, Algarra JL, Tormo M, Martinez P, Serrano J, Herrera P, Ramos F, Salamero O, Lavilla E, Gil C, Lopez Lorenzo JL, Vidriales MB, Labrador J, Falantes JF, Sayas MJ, Paiva B, Barragan E, Prosper F, Sanz MA, Martinez-Lopez J, Montesinos P, On Behalf Of The Programa Para El Estudio de la Terapeutica En Hemopatias Malignas Pethema Cooperative Study Group. The Mutational Landscape of Acute Myeloid Leukaemia Predicts Responses and Outcomes in Elderly Patients from the PETHEMA-FLUGAZA Phase 3 Clinical Trial. Cancers (Basel). 2021 May 18;13(10):2458. doi: 10.3390/cancers13102458.

    PubMed 34070172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azacitadine, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 1 site 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 7 inclusion and 10 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 6 Apr 2020. 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 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 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?

Efficacy (overall survival (OS) attained without increasing the therapy-related toxicity or decreasing the patients QoL. (time frame: 4 years). 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 NCT02319135, which also lists 1 linked publication.

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 6 Apr 2020.

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