Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML

NCT06536010 | Recruiting

• 1 other identifier: HEYLL202403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR)

  A. No symptoms or signs of leukemia cell infiltration, normal or near-normal life; B. Blood counts: Hb ≥ 100g/L (males) or ≥ 90g/L (females and children), absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L. No leukemia cells in peripheral blood leukocyte classification; C. Bone marrow morphology: Less than or equal to 5% of myeloblasts (type I + type II) (primitive monocytes + immature monocytes or primitive lymphocytes + immature lymphocytes), normal red blood cells and megakaryocytes; D. No extramedullary leukemia (no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular masses, central nervous system involvement).

  The period of 2 months from the start of treatment.

Secondary Outcomes (5)

• Partial Remission (PR)

  The period of 1 month from the start of treatment.

• Complete Remission with incomplete blood count recovery (CRi)

  The period of 1 month from the start of treatment.

• Overall Response Rate (ORR)

  The period of 4 months from the start of treatment.

• Morphologic leukemia-free state (MLFS)

  The period of 1 month from the start of treatment.

• Overall survival, OS

  The period of 2 years from the start of treatment.

Study Arms (1)

VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML)

EXPERIMENTAL

AZA: 75mg/m2 on days 1-7 VEN: 100mg on day 1, 200mg on day 2, 400mg on days 3-28 G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25\*10E9/L) In the induction phase of the ND-AML treatment protocol, VEN+AZA+G-CSF is administered. At the end of the induction phase, the efficacy is evaluated. If the patient achieves complete remission (CR), the original treatment protocol is continued for consolidation. If the patient achieves partial remission (PR), the original treatment protocol is repeated for induction until the patient achieves CR or shows no response (NR), progressive disease (PD), or relapse (PR/NR/PD). If the patient shows no response or progressive disease, the study is concluded.

Drug: Venetoclax 100 mg d1，200 mg d2，400 mg d3-28；

Interventions

Venetoclax 100 mg d1，200 mg d2，400 mg d3-28； DRUG

VAG in the induction phase of the ND-AML treatment protocol

Also known as: AZA 75mg/m2 on days 1-7, G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25*10E9/L)

VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, regardless of gender.
• Diagnosis of AML (excluding APL) according to the 2022 World Health Organization (WHO) diagnostic criteria.
• ECOG performance status of 0-2.
• For female participants of childbearing potential or male participants with female partners of childbearing potential, effective contraceptive measures must be taken throughout the entire treatment period and for 6 months after the treatment period.
• Expected survival of at least 3 months.
• Ability to understand and willingness to participate in the study, and signing an informed consent form.

You may not qualify if:

• Acute promyelocytic leukemia (M3 subtype).
• Central nervous system leukemia.
• Severe uncontrolled infection or other major diseases.
• Heart failure: Ejection fraction (EF) \< 50%, New York Heart Association (NYHA) class II or above.
• Impaired liver or kidney function: Serum total bilirubin ≥ 2.0 mg/dl, AST ≥ 3 times the upper limit of normal, serum creatinine clearance rate (Ccr) ≥ 50 ml/min, arterial oxygen saturation (SpO2) \< 92%.
• Human immunodeficiency virus (HIV) positive.
• Active hepatitis B or C.
• Pregnant or lactating women.
• Other conditions in which the investigator deems the participant unsuitable for the study.

Sponsors & Collaborators

• Yang Xiaotian: lead

Study Sites (1)

Huai'an Second People's Hospital

Huai'an, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Xiaotian Yang

CONTACT

15695110492; 15695110492@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 INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: November 3, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

CN (1)