NCT03455504

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 26, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6.2 years

First QC Date

February 28, 2018

Last Update Submit

April 9, 2024

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaVenetoclax

Outcome Measures

Primary Outcomes (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).

    At 24 months from study entry

Study Arms (2)

Cohort 1

EXPERIMENTAL

FLAI + V400 mg

Drug: Venetoclax

Cohort 2

EXPERIMENTAL

FLAI + V600 mg

Drug: Venetoclax

Interventions

VenetoclaxDRUG

Venetoclax add in combination with fludarabine, cyratabine and idarubicine

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Ematologia - ASST Papa Giovanni XXIII

Bergamo, Italy

Location

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

Bologna, Italy

Location

Spedali Civili - Azienda Ospedaliera U.O. Ematologia

Brescia, Italy

Location

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

Catania, Italy

Location

A.O.U. Careggi - Ematologia

Florence, Italy

Location

Irccs Aou San Martino - Genova - Uo Clinica Ematologica

Genova, Italy

Location

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

Meldola, Italy

Location

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

Milan, Italy

Location

Ospedale Niguarda "Ca Granda" SC Ematologia

Milan, Italy

Location

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

Milan, Italy

Location

Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

Pagani, Italy

Location

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

Parma, Italy

Location

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

Pavia, Italy

Location

Dipartimento Oncologico - Ospedale S. Maria delle Croci

Ravenna, Italy

Location

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

Roma, Italy

Location

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

Roma, Italy

Location

Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

Rozzano, Italy

Location

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

Salerno, Italy

Location

Aou Senese - Uoc Ematologia E Trapianti

Siena, Italy

Location

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

Torino, Italy

Location

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

Torino, Italy

Location

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

Location

Related Publications (1)

  • 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.

    PMID: 40048742DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Giovanni Martinelli

    Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola

    STUDY CHAIR

  • Fabio Ciceri

    Istituto S. Raffaele, Milan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study run-in and phase II
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 6, 2018

Study Start

October 26, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

IT(22)