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Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

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ClinicalTrials.gov Identifier: NCT04589728
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Drug: Venetoclax plus HMA

Detailed Description:
This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in patients with AML unfit for intensive chemotherapy in a "real-life" scenario. At least 104 AML adult patients ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021 will be enrolled. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit Patients With Acute Myeloid Leukemia Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023


Group/Cohort Intervention/treatment
Study group
All patients being observed during the study duration.
Drug: Venetoclax plus HMA
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 15 months ]
    Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with a diagnosis of AML ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021.
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years with a diagnosis of previously untreated primary or secondary AML;
  • Deemed ineligible for intensive chemotherapy because of age (≥75 years), performance status or comorbidities as defined by the treating physicians, according to SIE/SIES/GITMO criteria;
  • Eligible to receive the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021;
  • Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

  • Acute promyelocytic Leukemia;
  • Previous first-line treatments for AML;
  • Previous treatments with HMA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589728


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04589728    
Other Study ID Numbers: AML2320
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
venetoclax
unfit AML patients
Hypomethylating agents
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Venetoclax
Antineoplastic Agents