Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax

NCT04763928 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: AML2420
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 33

Brief Summary

Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy investigating a combination regimen including VEN and DEC.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Efficacy of VEN-DEC regimen (event free survival)

  Evaluation of the event free survival at 1 year of an experimental VEN-DEC combination arm in patients with AML secondary to MPN and unfit for intensive therapeutic strategy

  at 1 year

Study Arms (1)

VenDec

EXPERIMENTAL

Patients will receive a combination of VENETOCLAX (400 mg per day orally on days 1 to 28 of 28-days courses) and DECITABINE (20 mg/sqm intravenously on days 1 to 5 of 28-days courses)

Drug: Venetoclax+Decitabine

Interventions

Venetoclax+Decitabine DRUG

Patients will receive treatment with a combination of decitabine and venetoclax as follows: * Decitabine 20 mg/sqm intravenously on days 1 to 5 of 28-days courses * Venetoclax 400 mg per day orally on days 1 to 28 of 28-days courses; a dose escalation period is provided at first cycle (ramp-up) in which VEN is administered as follows: 100 mg on day -2, 200 mg on day -1, and 400 mg on day 1, a dose that is continued subsequently, daily, for 28-day cycles. In case of achievement of response, the treatment will be continued until disease progression or death by other causes.

VenDec

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with AML secondary to myeloproliferative neoplasms (sAML), untreated, newly diagnosed, according to WHO 2016 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization
• Patients unfit for intensive treatment modalities at the discretion of the investigator.
• ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
• Signed written informed consent according to ICH/EU/GCP and national local laws.
• Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial

You may not qualify if:

• Diagnosis of de novo AML
• Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin ≥2,5 x ULN and/or ALT\>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with Creatinine Clearance (CrCl) level \<30ml/min (calculated by Cockcroft Gault formula) (unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following adequate supportive measures.
• Pre-existing HIV positive serology (i.e. already known before enrolment). The participation to the study will require serology testing for HIV positivity at baseline: in case of HIV positivity or refusal to perform HIV testing, the patient will be considered not eligible.
• Uncontrolled bacterial or fungal infections
• QTc \>470 msec on screening ECG (Fridericia's formula)
• A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 6 months.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (33)

Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Ematologia AOU delle Marche

Ancona, Italy

Location

Ematologia AOU Policlinico Bari

Bari, Italy

Location

Ematologia ASST Papa Giovanni XXIII

Bergamo, Italy

Location

Ematologia IRCCS AOU di Bologna

Bologna, Italy

Location

Ematologia ASST Spedali Civili di Brescia

Brescia, Italy

Location

Ematologia Businco

Cagliari, Italy

Location

Ematologia Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, Italy

Location

Ematologia AOU Policlinico Rodolico-San Marco

Catania, Italy

Location

Ematologia A.O.U Arcispedale S.Anna

Cona, Italy

Location

Ematologia Ospedale A.Carle

Cuneo, Italy

Location

Az. Ospedaliero - Universitaria Careggi

Florence, Italy

Location

Ematologia IRCCS Ospedale Policlinico San Martino

Genova, Italy

Location

Ematologia AOU di Modena

Modena, Italy

Location

Ematologia AORN Cardarelli

Napoli, Italy

Location

Ematologia Federico II

Napoli, Italy

Location

Ematologia P.O. A.Tortora

Pagani, Italy

Location

Ematologia AOU Policlinico Giaccone

Palermo, Italy

Location

Ematologia Santa Maria della Misericordia

Perugia, Italy

Location

Ematologia PO Santo Spirito ASL Pescara

Pescara, Italy

Location

Ematologia Ospedale S.M.delle Croci

Ravenna, Italy

Location

Ematologia AOU S.Andrea

Roma, Italy

Location

Ematologia Fondazione PTV

Roma, Italy

Location

Ematologia Ospedale Sant'Eugenio

Roma, Italy

Location

Ematologia Policlinico Gemelli

Roma, Italy

Location

Ematologia Policlinico Umberto I

Roma, Italy

Location

Ematologia Policlinico Santa Maria alle Scotte

Siena, Italy

Location

Ematologia A.O.S. Maria Di Terni

Terni, Italy

Location

Ematologia Città della Salute e della Scienza

Torino, Italy

Location

Ematologia ORDINE MAURIZIANO DI TORINO

Torino, Italy

Location

Ematologia Santa Maria della Misericordia

Udine, Italy

Location

Ematologia ASST SETTE LAGHI

Varese, Italy

Location

Ematologia Ospedale Belcolle

Viterbo, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: December 3, 2021
• Primary Completion: October 25, 2024
• Study Completion: April 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

IT (33)