Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

NCT06232694 | Recruiting

• 1 other identifier: 2023-SR-508
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• The composite complete remission rate (CR+CRi)

  Composite complete remission rate: the proportion of patients who achieve complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) at the end of induction therapy (CR+CRi).• CR is defined as meeting all of the following criteria: ① bone marrow blasts \<5%, no circulating or Auer rod blasts; ② no extramedullary disease; ③ ANC ≥1.0 × 109 /L; ④ platelet count ≥100 × 109 /L.• CRi is defined as PLT ≤100 × 109 /L and/or ANC ≤1.0 × 109 /L, with other criteria for CR being met.

  Four months from the start of initial induction therapy.

Secondary Outcomes (1)

• The incidence of hematological adverse reactions during induction therapy

  Four months from the start of initial induction therapy.

Other Outcomes (4)

• The duration of neutropenia

  Four months from the start of initial induction therapy.

• Minimal residual disease (MRD)

  Four months from the start of initial induction therapy.

• Duration of response (DoR) in complete remission (CR) or complete remission with incomplete hematological recovery (CRi)

  Four months from the start of initial induction therapy.

Study Arms (1)

Induction therapy and consolidation therapy after remission

EXPERIMENTAL

Induction therapy:Venetoclax + idarubicin + cytarabine Consolidation therapy after remission:Venetoclax + cytarabineIf The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Drug: Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;; Drug: Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;; Other: utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Interventions

Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration; DRUG

Induction Phase Regimen

Also known as: Idarubicin (Idarubicin): 10-12mg/m2 on days 1 to 3; intravenous infusion, ;Cytarabine (Cytarabine): 100mg/m2 on days 1 to 7; intravenous infusion or subcutaneous injection.

Induction therapy and consolidation therapy after remission

Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration; DRUG

Consolidation therapy after remission

Also known as: Cytarabine: 2g/m2 every 12 hours on day 1 to day 3; intravenous infusion;

Induction therapy and consolidation therapy after remission

utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT). OTHER

Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Induction therapy and consolidation therapy after remission

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
• Age between 18 and 60 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
• Cardiac ultrasound LVEF ≥ 45%.
• Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
• Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration).
• Signed informed consent form.

You may not qualify if:

• Acute promyelocytic leukemia (APL).
• Relapsed/refractory AML patients.
• AML patients with known involvement of the central nervous system (CNS).
• Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
• Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
• Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity.
• Participants with chronic respiratory disease requiring continuous oxygen therapy.
• Patients unable to take oral medications or with malabsorption syndrome.
• Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
• Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Huai'an First People's Hospital: collaborator
• Yancheng First People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Administration, Oral; Idarubicin; Infusions, Intravenous; Cytarabine; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Administration, Intravenous; Infusions, Parenteral; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Injections

Central Study Contacts

Ming Hong, MD

CONTACT

+8613914722662; minniehm122@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)