Clinical Study of Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

NCT05918198 | Unknown Phase 2

• 1 other identifier: RDL2022-13
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• CR/CRi rate

  the rate of complete remission or complete remission with incomplete hematologic recovery

  2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)

• CR/CRi rate

  the rate of complete remission or complete remission with incomplete hematologic recovery

  2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)

Secondary Outcomes (7)

• MRD status

  2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)

• MRD status

  2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)

• objective remission rate（ORR）

  2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)

• objective remission rate（ORR）

  2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)

• Progression-free survival (PFS)

  Throughout the whole research process, assessed up to 24 months

Study Arms (1)

Ven+CAG

EXPERIMENTAL

Venetoclax plus CAG regimen

Drug: Ven+CAG

Interventions

Ven+CAG DRUG

100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day. Ara-C 10mg/m2, ih, q12h × 14d； Acla 20mg/d × 4d； G-CSF 5ug/kg × 14d (WBC \> 30 × 10\^9/L pause)

Also known as: Venetoclax plus CAG regimen

Ven+CAG

Eligibility Criteria

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

You may qualify if:

• years ≤ age ≤ 75 years, male and female are not limited.
• According to bone marrow morphology and immunophenotype, it was diagnosed as acute myeloid leukemia ( WHO 2016 diagnostic criteria).
• Morphological recurrence after complete remission (CR) (leukemic cells in the peripheral blood of CR patients or more than 5% of the blasts in the bone marrow or new pathological hematopoiesis or extramedullary leukemic cell infiltration) or acute myeloid leukemia patients who did not achieved CR after 1 cycle of chemotherapy.
• The ECOG (Eastern Cancer Cooperation Group of the United States) PS score is 0-1.
• The expected survival time is ≥ 12 weeks.
• Female patients of childbearing age need to undergo pregnancy examination before receiving chemotherapy, and must agree to take effective contraceptive measures during treatment.
• Subjects volunteered to participate, fully informed consent, signed an informed consent, and good compliance.

You may not qualify if:

• Other malignant hematological diseases that do not conform to the diagnosis of acute myeloid leukemia.
• Allergy to any drugs involved in the project.
• History of serious cardiovascular and cerebrovascular diseases: ① Congestive heart failure, unstable angina pectoris, myocardial infarction, stroke or poorly controlled arrhythmia with NYHA grade II or above occurred within 12 months before enrollment，LVEF (left ventricular ejection fraction)\<50% by color Doppler ultrasound，Corrected QT interval (QTc)\>480ms (calculated by Fridericia method, if the QTc is abnormal, it can be detected continuously for 3 times every 2 minutes, and the average value is taken)，Hypertension difficult to control by drugs (systolic blood pressure (BP) ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg) (based on the average of ≥ 3 BP readings obtained from ≥ 2 measurements)，Have had hypertensive crisis or hypertensive encephalopathy in the past.
• There are other obvious bleeding tendencies or evidence of major coagulation disorders: ①Hemoptysis of any reason occurred within 2 weeks before enrollment，② Thrombosis or embolism occurred within 6 months before enrollment，③ Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin therapy) be used within 2 weeks before enrollment④ Antiplatelet therapy is required.
• Abnormal liver function: total bilirubin\>3 mg/dL；Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 5 × Upper limit of normal value (ULN).
• Abnormal renal function: serum creatinine ≥ 1.5 × ULN, or the creatinine clearance rate (CrCl) calculated according to Cockroft-Gault formula is less than 60 mL/min (if the calculated CrCl is less than 60 mL/min, the researcher may ask to confirm the 24-hour CrCl, in this case, the subjects with 24-hour CrCl less than 60 mL/min should be excluded).
• Other serious diseases that may limit the patient's participation in this clinical trial (including but not limited to other malignant tumors, active infection, serious uncured wounds, active ulcers and untreated fractures, history of human immunodeficiency virus infection, and receiving allogeneic stem cells or solid organ transplantation).
• Cannot swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption.
• Other clinical trials are being conducted.
• Unable to understand or cooperate to complete the research protocol.
• Pregnant and lactating patients

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; CAG protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Wen-Jing Yu, M.D.

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Wen-Jing Yu, M.D.

CONTACT

18813187365; yuwenjing789@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University People's Hospital

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 26, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)