Decitabine and HQP1351-based Chemotherapy Regimen for the Treatment Advanced CML

NCT05376852 | Unknown Phase 2 DMC

• 1 other identifier: CML220520
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well the combination of based decitabine and olverembatinib（HQP1351)chemotherapy work for the treatment of blast phase or accelerated phase chronic myelogenous leukemia. Drugs used in chemotherapy such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HQP1351 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and ponatinib based chemotherapy may help to control blast phase or accelerated phase chronic myelogenous leukemia.

Conditions

Chronic Myeloid Leukemia in Myeloid Blast Crisis; Chronic Myeloid Leukaemia Transformation; Chronic Myeloid Leukemia - Accelerated Phase; Chronic Myeloid Leukemia in Lymphoid Blast Crisis

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Defined as the proportion of patients achieving complete remission (CR) + CR with incomplete count recovery (CRi) occurring at the end of 2 cycles of treatment. Will be estimated along with the 95% credible interval. Patients who drop out of the study before completing 2 cycles and have been treated will be censored for the primary endpoint analysis.

  At 12 weeks

Secondary Outcomes (3)

• Relapse-free survival

  3 years

• Event-free survival

  3 years

• Overall survival

  assessed up to 3 years

Study Arms (1)

treatment group

EXPERIMENTAL

Based decitabine and olverembatinib（HQP1351)chemotherapy

Combination Product: based decitabine and olverembatinib（HQP1351)chemotherapy

Interventions

based decitabine and olverembatinib（HQP1351)chemotherapy COMBINATION_PRODUCT

AP-CML treated with decitabine 10mg/m2 d1-5 intravenously (IV) over 60 minutes on days 1-5 and HQP1351 40mg qod every 28 days.After completion of HQP1351 lead-in, patients will receive HQP1351 PO qod on days 1-28 of subsequent cycles. BC-CML:treated with decitabine 20mg/m2 d1-5 IV on days 1-5 and HQP1351 40mg qod every 28 days,with or without other chemotherapy Drugs

treatment group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• myeloid accelerated phase (AP)-chronic myelogenous leukemia (CML) or blast phase (BP)-CML (either t\[9;22\] and/or BCR-ABL1 positive by fluorescent in situ hybridization or polymerase chain reaction). Both untreated and relapsed/refractory patients are eligible
• Performance status =\< 3 (Eastern Cooperative Oncology Group \[ECOG\] scale)
• Total serum bilirubin =\< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI) Alanine aminotransferase (ALT) =\< 1.5 x ULN, unless due to the underlying leukemia approved by the PI Aspartate aminotransferase (AST) =\< 1.5 x ULN unless due to the underlying leukemia approved by the PI Creatinine clearance \>= 30 mL/min Serum lipase =\< 1.5 x ULN Amylase =\< 1.5 x ULN Ability to swallow Signed informed consent

You may not qualify if:

• Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment) History of acute pancreatitis within 6 months of study or history of chronic pancreatitis Uncontrolled hypertriglyceridemia (triglycerides \> 450 mg/dL) Active secondary malignancy that in the investigator's opinion will shorten survival to less than 1 year Active grade III-V cardiac failure as defined by the New York Heart Association criteria
• Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
• Myocardial infarction (MI), stroke, revascularization, unstable angina or transient ischemic attack within 6 months Left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment Diagnosed or suspected congenital long QT syndrome Clinically significant atrial or ventricular arrhythmias (such as uncontrolled, clinically significant atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes) as determined by the treating physician Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 480 msec) unless corrected after electrolyte replacement History of venous thromboembolism including deep venous thrombosis or pulmonary embolism within the past 3 months, excluding line-associated deep venous thrombosis (DVT) of the upper extremity Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg; systolic \> 150 mmHg)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: professor

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)