A Study of Olverembatinib in the Treatment of Ph+ ALL

NCT05466175 | Unknown Phase 2

• 1 other identifier: SZ-ALL01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib. The main purpose of the study is to evaluate the efficacy and safety of Olverembatinib in Ph+ ALL patients.

Conditions

Philadelphia-Positive ALL

Keywords

Olverembatinib, Ph+ALL, adult, de novo

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Complete Molecular Remission

  Will be estimated along with the 95% credible intervals.

  From Induction through the end of one cycle of Hyper-CVAD A and B (approximately 3 months) (Cycle length is equal to [=] 28 days) ]

Secondary Outcomes (5)

• Percentage of Participants with CR and Incomplete Complete Remission (CRi)

  At the end of consolidation therapy (approximately 9 months) and one year after allo-HSCT

• Duration of Complete Molecular Remission

  From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 to 4 years.

• Event-free survival (EFS)

  From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years ]

• Overall survival (OS)

  From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.

• Incidence of adverse events (AEs)

  Up to approximately 2 to 4 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

combination of Olverembatinib with chemotherapy

Drug: Olverembatinib; Drug: Prednisone; Drug: Vincristine

Interventions

Olverembatinib DRUG

Given PO

Treatment Group

Prednisone DRUG

Given Intravenous

Treatment Group

Vincristine DRUG

Given Intravenous

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
• Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. Participants who only received preconditioning can be enrolled.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
• Organ function as indicated by the following laboratory indicators must be met:
• \) Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN; 2) Total bilirubin≤1.5×ULN; 3) Serum creatinine≤1.5×ULN or 24-hour calculated creatinine clearance≥50mL/min when serum creatinine \>1.5×ULN; 4) Amylase≤1.5×ULN, lipase≤1.5×ULN; 5) Cardiac ejection fraction (EF) \> 50%, pulmonary artery systolic blood pressure ≤ 50mmHg; 6) QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females; 7) PT, APTT and INR≤1.5×ULN.
• \. Willingness and ability to comply with study procedures and follow-up examination.

You may not qualify if:

• The presence of central nervous system (CNS) or testicular active ALL.
• Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
• Uncontrolled active infection.
• Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.
• Patients who have a history of clinically significant CNS lesions or is currently suffering from clinically significant CNS lesions.
• Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.
• Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension.
• Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL.
• Patients who have any other malignant tumors that require treatment.
• Patients who have a history of pancreatitis or a history of alcohol abuse.
• Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L).
• Patients who are pregnant, planning to become pregnant or breastfeeding.
• Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug.
• Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures.
• Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.

Sponsors & Collaborators

• Chen Suning: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

olverembatinib; Prednisone; Vincristine

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 20, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-07

Locations

CN (1)