Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

NCT ID: NCT05805098

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2028-03-01

Brief Summary

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Detailed Description

This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before. In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML. This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venetoclax Combined With Homoharringtonine and Cytarabine

All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.

Homoharringtonine

Intervention Type: DRUG

On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.

Cytarabine

Intervention Type: DRUG

On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Interventions

Venetoclax

Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.

Intervention Type: DRUG

Homoharringtonine

On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.

Intervention Type: DRUG

Cytarabine

On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Intervention Type: DRUG

Other Intervention Names

VEN; HHT

Eligibility Criteria

Inclusion Criteria

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

2. patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.

3. Patients > 18 to ≤ 60 years

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2

5. Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count < 25 × 109 /L (hydroxyurea is permitted to meet this criterion)

Exclusion Criteria

1. > 60 years of age or <18 years of age

2. Acute promyelocytic leukemia (M3)

3. Patient is ineligible for treatment with intensive chemotherapy

4. Patient with active infection not controlled, active bleeding from vital organs

5. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study

6. Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.

7. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.

8. Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C

9. Patients deemed unsuitable for enrolment by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huiying Qiu, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

Qiu Huiying

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huiying Qiu, PhD

Role: CONTACT

qiuhuiying@aliyun.com

13912792913

Depei Wu, PhD

Role: CONTACT

drwudepei@163.com

67781856

Facility Contacts

Huiying Qiu, PhD

Role: primary

qiuhuiying@aliyun.com

13912792913

Other Identifiers

SZQ001

Identifier Type: -

Identifier Source: org_study_id