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

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...

Lead sponsor: Nanfang Hospital, Southern Medical University•1 locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Sponsors

Lead Sponsor

Nanfang Hospital, Southern Medical University

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)

Related studies

UNKNOWNPhase 2

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation

NCT03883100 · Chronic Myeloid Leukemia - Accelerated Phase

UNKNOWNPhase 2

Nilotinib-Chemotherapy in CML Myeloid BP or Bcr-abl(+) AML

NCT01690065 · Chronic Myeloid Leukemia in Myeloid Blast Crisis, Untreated Adult Acute Myeloid Leukemia

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 8, 2022Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE2

Enrollment40

Start dateDec 2021

Last updatedDec 8, 2022

Condition

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

Locations shown

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2022Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions