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

November 7, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

A Phase 2, Prospective, Multi-center Intervention Trial in Patients With Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasms Unfit for Intensive Chemotherapy Investigating a Treatment Combination Including Decitabine and Venetoclax

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 to improve the survival outcome.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy
        • Ematologia AOU delle Marche
      • Bari, Italy
        • Ematologia AOU Policlinico Bari
      • Bergamo, Italy
        • Ematologia ASST Papa Giovanni XXIII
      • Bologna, Italy
        • Ematologia IRCCS AOU di Bologna
      • Brescia, Italy
        • Ematologia ASST Spedali Civili di Brescia
      • Cagliari, Italy
        • Ematologia Businco
      • Castelfranco Veneto, Italy
        • Ematologia Istituto Oncologico Veneto IRCCS
      • Catania, Italy
        • Ematologia AOU Policlinico Rodolico-San Marco
      • Cona, Italy
        • Ematologia A.O.U Arcispedale S.Anna
      • Cuneo, Italy
        • Ematologia Ospedale A.Carle
      • Firenze, Italy
        • Az. Ospedaliero - Universitaria Careggi
      • Genova, Italy
        • Ematologia IRCCS Ospedale Policlinico San Martino
      • Modena, Italy
        • Ematologia AOU di Modena
      • Napoli, Italy
        • Ematologia AORN Cardarelli
      • Napoli, Italy
        • Ematologia Federico II
      • Pagani, Italy
        • Ematologia P.O. A.Tortora
      • Palermo, Italy
        • Ematologia AOU Policlinico Giaccone
      • Perugia, Italy
        • Ematologia Santa Maria della Misericordia
      • Pescara, Italy
        • Ematologia PO Santo Spirito ASL Pescara
      • Ravenna, Italy
        • Ematologia Ospedale S.M.delle Croci
      • Roma, Italy
        • Ematologia AOU S.Andrea
      • Roma, Italy
        • Ematologia Fondazione PTV
      • Roma, Italy
        • Ematologia Ospedale Sant'Eugenio
      • Roma, Italy
        • Ematologia Policlinico Gemelli
      • Roma, Italy
        • Ematologia Policlinico Umberto I
      • Siena, Italy
        • Ematologia Policlinico Santa Maria alle Scotte
      • Terni, Italy
        • Ematologia A.O.S. Maria Di Terni
      • Torino, Italy
        • Ematologia Città della Salute e della Scienza
      • Torino, Italy
        • Ematologia ORDINE MAURIZIANO DI TORINO
      • Udine, Italy
        • Ematologia Santa Maria della Misericordia
      • Varese, Italy
        • Ematologia ASST SETTE LAGHI
      • Viterbo, Italy
        • Ematologia Ospedale Belcolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Patients unfit for intensive treatment modalities at the discretion of the investigator.
  3. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
  4. Signed written informed consent according to ICH/EU/GCP and national local laws.
  5. 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

Exclusion Criteria:

  1. Diagnosis of de novo AML
  2. 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.
  3. 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.
  4. Uncontrolled bacterial or fungal infections
  5. QTc >470 msec on screening ECG (Fridericia's formula)
  6. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy < 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VenDec
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of VEN-DEC regimen (event free survival)
Time Frame: at 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

October 25, 2024

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML2420

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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