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Trial Title:
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL
NCT ID:
NCT05594784
Condition:
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Prednisone
Vincristine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olverembatinib
Description:
a third-generation TKI
Arm group label:
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Arm group label:
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
Intervention type:
Drug
Intervention name:
prednisone
Description:
Glucocorticoids
Arm group label:
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Anti-tumor alkaloids
Arm group label:
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
Summary:
The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The
third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior
efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not
available in mainland China. Olverembatinib is the only third-generation TKI drug
currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2,
and small exploratory clinical studies have demonstrated that venetoclax in combination
with ponatinib showed high rates of CR as well as molecular response in
relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of
olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in
patients with newly diagnosed Ph+ ALL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients aged 14 years or older
2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL
positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be
diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM)
criteria, including bone marrow morphology, immunophenotype, cytogenetic and
molecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination
3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
4. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of
normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate
aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver
is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline
phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes:
Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound
ejection fraction ≥ 45%;
5. Subject has provided written informed consent prior to any screening procedure
Exclusion Criteria:
1. Lymphoid blast crisis of chronic myelocytic leukemia (CML)
2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI
and/or radiotherapy, except for appropriate pre-treatment)
3. Clinical manifestations of CNS or extramedullary involvement with ALL
4. Patients with a history of myocardial infarction within 12 months or clinically
significant cardiac disorders disease (e.g., unstable angina, congestive heart
failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)
5. Uncontrolled active serious infections that could, in the investigator's opinion,
potentially interfere with the completion of treatment
6. Known HIV seropositivity
7. History of acute pancreatitis within 1 year of study screening or history of chronic
pancreatitis
8. Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
9. Female patients who are pregnant or breast feeding
10. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of
>7.5%. Patients with preexisting, well-controlled diabetes are not excluded
11. Any serious psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianxiang Wang, Dr.
Phone:
86-22-23909120
Email:
wangjx@medmail.com.cn
Investigator:
Last name:
Jianxiang Wang, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Ying Wang, Dr.
Email:
Sub-Investigator
Start date:
October 8, 2022
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594784
