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Acute Myeloid LeukemiaPhase 2V-FIRSTNCT03455504

Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia

A Phase 2 study testing Venetoclax in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 22 sites in Italy.

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

This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
22 sitesItaly
Study dates
26 Oct 2018to 15 Jul 2026
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with documented/confirmed new onset non-m3 acute myeloid leukemia, according to WHO 2017 will be eligible for this study.
  • Hematological illness has to be graded intermediate or high risk according ELN criteria
  • Patients ≥ 18 years old and ≤ 65 years old
  • ECOG performance status ≤ 2.
  • Patients with a life expectancy >12 weeks
  • Patients may have AML which has arisen from prior therapies or other antecedent disorder
Show all 18Show fewer
  • Adequate hepatic function
  • Adequate pancreatic function
  • Adequate renal function assessed by: Serum creatinine within reference laboratory ranges or creatinine clearance (by Cockcroft Gault formula, see Appendix 2) ≥ 50 mL/min for patients in whom, in the Investigator's judgment, serum creatinine level may not adequately reflect renal function.
  • All non-hematological adverse events must have resolved to NCI-CTCAE Grade ≤ 2 prior to starting therapy.
  • Patients must be considered by Investigator suitable to receive combination chemotherapy.
  • Combination chemotherapy has not to be considered toxic without expectation of any benefit for the patient
  • For females of childbearing potential, a negative pregnancy test must be documented within 72 hours prior to the first study drug administration.
  • All patients must be willing to use effective methods of contraception, during the treatment period and for 100 days after the last dose of Venetoclax. Female patients must be postmenopausal (≥ 1 year of amenorrhea), surgically sterile, or they must agree to use 2 adequate methods of contraception with at least one method with a failure rate of
  • ≤ 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomized partner) and the second preferably a physical barrier method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Patient must be willing to submit the blood sampling and bone marrow sampling for the PK and PD analyses and exploratory biomarkers.
  • Ability to understand and willingness to sign an informed consent form.
  • Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Who cannot join

  • Patients with low risk AML according ELN criteria
  • Patients with current clinical evidence of CNS leukemia.
  • Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000/mm3. HU and 6MP must be discontinued at the time of initiation of study medications.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study including but not limited at:
  • unstable angina
  • Patients who are on anti-microbial agents with therapeutic intent

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Italy22 sites

  • Ematologia - ASST Papa Giovanni XXIII

    Bergamo

  • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

    Bologna

  • Spedali Civili - Azienda Ospedaliera U.O. Ematologia

    Brescia

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • A.O.U. Careggi - Ematologia

    Florence

  • Irccs Aou San Martino - Genova - Uo Clinica Ematologica

    Genova

  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori IRST

    Meldola

  • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia

    Milan

  • Ospedale Niguarda "Ca Granda" SC Ematologia

    Milan

  • U.O. Ematologia e Trapianto di Midollo Ist. Scientifico Ospedale San Raffaele

    Milan

  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

    Pagani

  • U.O.C. Ematologia e CTMO Az Ospedaliero Universitaria

    Parma

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia

  • Dipartimento Oncologico - Ospedale S. Maria delle Croci

    Ravenna

  • Università degli Studi "Sapienza" Dip. Biotecnologie Cellulari ed Ematologia

    Roma

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma

  • Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

    Rozzano

  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

    Salerno

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

    Torino

  • Dipartimento di Oncologia ed Ematologia S.C. -Città della Scienza di Torino San Giovanni Battista

    Torino

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza

Other trials in Italy

About this study

Official title: Study Investigating Safety, Tolerability and Effectiveness of Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction of New Onset Non-M3 Acute Myelid Leukemia

This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis.

Read the detailed description

Intensive treatment of Acute Leukemia, multidrug based chemotherapy induction, achieves complete remission (CR) rates ranging from 50% to 80%. Nonetheless, the majority (60- 70%) of responding patients will eventually relapse.

Patients with non-low risk leukemia according most diffuse risk scores have a poor prognosis and a short survival. For these patient traditional chemotherapy seems to be ineffective, even with BMT consolidation, probably due to activation of survival pathways in Leukemia cells, so that novel therapeutic interventions should be attempted.

This study will test the effectiveness and safety of Venetoclax, a selective BCL2 inhibitor, in combination with standard induction regimen.

Inhibiting anti-apoptotic pathway of BCL2, the investigators expect to improve success rate of standard chemotherapies.

Being tested
Venetoclax
Keywords
Acute myeloid leukemia, Venetoclax
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.

  • VenetoclaxDrug

    Venetoclax add in combination with fludarabine, cyratabine and idarubicine

Study groups in NCT03455504
Study groupRoleWhat they receive
Cohort 1ExperimentalFLAI + V400 mg
Receives: Drug: Venetoclax
Cohort 2ExperimentalFLAI + V600 mg
Receives: Drug: Venetoclax

What is being measured

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

  1. Number of patients achieving complete response (CR) after course 1 or course 2 if course 2 is administered (CR + CRi + CRp)

    Efficacy in new onset, non ELN Low risk AML (safety run-in, part1, and part2). Effectiveness of Venetoclax added in combination with chemotherapy in obtaining Complete remission in new onset, non ELN Low risk AML (safety run-in, part1, and part2).

    Measured: At 24 months from study entry

Timeline

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

  1. First posted6 Mar 2018
  2. Study start26 Oct 2018
  3. Primary completion21 Jul 2025
  4. Study completion15 Jul 2026

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Study run-in and phase II
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03455504
Sponsor's protocol ID
AML1718
Other IDs
2018-000392-33, 2018
Acronym
V-FIRST
Status last verified
Jul 2026
First submitted
28 Feb 2018
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Marconi G, Piciocchi A, Audisio E, Papayannidis C, Cerrano M, Minotti C, Paoloni F, Guolo F, Bocchia M, Rondoni M, Lico A, Carrabba MG, Della Porta MG, Frigeni M, Giaccone L, Beltrami G, Cattaneo C, Di Chio MC, Serio B, Crea E, Freilone R, Capria S, Curti A, Minetto P, la Sala E, Nanni J, Zannetti BA, Simonetti G, Bochicchio MT, Saglio G, Lemoli RM, Venditti A, Vignetti M, Fazi P, Martinelli G. Safety run-in and part 1 of GIMEMA AML1718: venetoclax combined with FLAI as induction treatment in non-low-risk AML. Blood Adv. 2025 May 27;9(10):2542-2552. doi: 10.1182/bloodadvances.2024014901.

    PubMed 40048742

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 22 sites in Italy.

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 18 inclusion and 6 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of patients achieving complete response (CR) after course 1 or course 2 if course 2 is administered (CR + CRi + CRp) (time frame: At 24 months from study entry). 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 NCT03455504, 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 20 Jul 2026.

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