Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

NCT06328179 | Recruiting

• 1 other identifier: KY-2023-058-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall response rate，ORR

  The morphological efficacy evaluation of the subjects is divided into four outcomes: complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), partial remission (PR), and no remission (NR). Among them, CR, CRh, CRi, MLFS, and PR are collectively referred to as ORR. The evaluation time point is on the 21st day after the start of chemotherapy. When the patient is first evaluated as CR/CRh/CRi, complete test results such as peripheral blood, bone marrow, and clinical symptoms are required.

  The period of 1 year from the start of treatment.

Secondary Outcomes (3)

• Overall survival, OS

  The period of 1 year from the start of treatment.

• Event free survival, EFS

  The period of 1 year from the start of treatment.

• Duration of remission, DOR

  The period of 2 year from the start of treatment.

Other Outcomes (2)

• Adverse event, AE

  The period of 1 year from the start of treatment.

• Treatment-related mortality, TRM

  The period of 1 year from the start of treatment.

Study Arms (1)

VHEA regimen in the treatment of ND-AML and RR-AML with MLL gene abnormalities.

EXPERIMENTAL

Venetoclax 100 mg d1，200 mg d2，400 mg d3-14； homoharringtoine, HHT 2 mg/m2，qd，d1-7； Etoposide 0.1 g，qd，d1-5； Cytarabine 100 mg/m2，qd，d1-7 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 100 mg d1，200 mg d2，400 mg d3-14；

Interventions

Venetoclax 100 mg d1，200 mg d2，400 mg d3-14； DRUG

VHEA -Induction Phase Regimen/Consolidation therapy after remission

Also known as: Homoharringtoine, HHT 2 mg/m2，qd，d1-7, Etoposide 0.1 g，qd，d1-5, Cytarabine 100 mg/m2，qd，d1-7

VHEA regimen in the treatment of ND-AML and RR-AML with MLL gene abnormalities.

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival time of at least 3 months.
• Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min.
• No other significant contraindications to chemotherapy as determined by the physician;
• Capable of understanding and willing to sign the informed consent form for this study.

You may not qualify if:

• Presence of other malignancies;
• Underwent cardiac vascular intervention or stent placement within 12 months prior to signing the informed consent, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease;
• Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding;
• Pregnant or lactating women;
• Participation in any other clinical study within 3 months prior to signing the informed consent;
• Any other condition deemed unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• Huai'an First People's Hospital: lead
• Zhenjiang First People's Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital）

Huai'an, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Cytarabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shandong Tao

CONTACT

15252393900; TSD8884@126.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: March 18, 2024
• First Posted: March 25, 2024
• Study Start: May 24, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CN (1)