Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06090786
Other study ID # AML2723
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date July 2027

Study information

Verified date April 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice. The main questions it aims to answer are: 1. kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques 2. impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.


Description:

This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes. Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included. Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 225
Est. completion date July 2027
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject must be = 18 years of age - Subject has diagnosis of AML according to WHO 2016 - Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start) - Subject is planned to receive front-line therapy with Azacitidine and Venetoclax - Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice - Subject must have assessable MRD by flow cytometry at screening BM evaluation - Signed written informed consent according to ICH/EU/GCP and national local laws Exclusion Criteria: - Diagnosis of BCR::ABL1-positive AML - Diagnosis of APL - AML with CNS involvement. - AML with extra-medullary localizations - Patients' unwillingness or inability to comply with the protocol requirements.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRD assessment
Bone marrow withdrawal for MRD quantification

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of MRD-negative patients within cycle 4 Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication 4 months
See also
  Status Clinical Trial Phase
Terminated NCT04044560 - Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant Phase 2
Recruiting NCT05959720 - Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02458014 - Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease Phase 2
Active, not recruiting NCT03233854 - CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Not yet recruiting NCT06358430 - Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) Phase 1
Not yet recruiting NCT05603156 - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive N/A
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT05601830 - Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease Phase 1
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT03241940 - Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Completed NCT03096782 - Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma Phase 2
Completed NCT05093192 - Mobilising Tumour and Immune Cells Via Exercise in Chronic Lymphocytic Leukaemia N/A
Recruiting NCT06230185 - ctDNA Based MRD Testing for NAC Monitoring in TNBC
Recruiting NCT02400970 - Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors N/A
Recruiting NCT02400827 - Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors N/A
Active, not recruiting NCT01894477 - Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 2
Active, not recruiting NCT04920188 - Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)