Study title
HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ ALL
Scientific title
A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) (ClinicalTrials.gov NCT04260022)
Indication and most important inclusion criteria
This study includes male or female patients 18 years and older with CML in chronic phase (CP) or accelerated phase (AP) or blast phase (BP) or with Ph+ ALL, with or without T315I mutation.
Eligible patients will be previously treated with and developed resistance or intolerance to at least three tyrosine kinase inhibitors (TKIs), including ponatinib, imatinib, dasatinib, nilotinib, or bosutinib. For patients with a T315I mutation, resistance or intolerance to ponatinib alone is acceptable.
To be considered for inclusion, patients must have adequate end-organ function, and an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.
Additional criteria may apply.
Short description of intervention
This is a phase 1b study to evaluate the pharmacokinetics of HQP1351 and to determine the recommended dose for phase 2 in subjects with CML CP, AP or BP or with Ph+ ALL, who have developed resistance or intolerance to at least three prior TKIs. The preliminary efficacy and safety of HQP1351 in these patients will be evaluated as well.
In this study, patients will receive HQP1351 at a dose of either 30 mg, 40 mg or 50 mg every other day for 28 days.
Type of study
Trial after therapy failure or intolerance
Current status
Recruiting
Study sponsor
Ascentage Pharma Group Inc.
Scientific lead / contact
Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
Principal investigator
Study chair: Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
United States
Alabama
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Principal Investigator: Omer Jamy, MD
Arkansas
Highlands Oncology
Rogers, Arkansas, 72758
Principal Investigator: Thad Beck, MD
California
City of Hope
Duarte, California, 91010
Principal Investigator: Paul Koller, MD
Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Principal Investigator: Anthony Hunter, MD
Maryland
University of Maryland
Baltimore, Maryland, 21201
Principal Investigator: Maria Baer, MD
Ohio
Cleveland Clinic
Cleveland, Ohio, 44195
Principal Investigator: Sudipto Mukherjee, MD
Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Elias Jabbour, MD
Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Principal Investigator: Vivian Oehler, MD
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Chronic phase
The earliest phase of CML development.
Resistance
The ability to withstand the effects of a drug, e.g. resistance of cancer cells to a specific therapy.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Bosutinib
Bosutinib (development name SKI-606, trade name Bosulif), a second generation tyrosine kinase inhibitor.
Also called Bosulif|SKI-606|SKI606
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
Ponatinib
Trade name: Iclusig, development name: AP24534; a third-generation tyrosine kinase inhibitor
Other names: AP24534|Iclusig.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
Chronic
Long-lasting, slowly developping
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
Acute
Of sudden onset, severe; of short duration.
TKIs
Tyrosine Kinase Inhibitors, a class of drugs that block an enzyme involved in the mechanism of division of cells
ECOG
Eastern Cooperative Oncology Group Index to classify the quality of life of cancer patients on a scale ranging from 0 (fully active, able to carry on all predisease activities without restriction) to 5 (death).
Also often referred to as ECOG performance status.
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
ASH
American Society of Hematology
HLA
Human Leukocyte Antigen - the proteins on the surface of all cells that must be matched for bone/stem cell transplants to avoid immune reactions of the donor's immune system against the body of the recipient
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
