BridgeMD
New treatment option for Precursor B-Cell Acute Lymphoblastic Leukemia
Official title Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL
ClinicalTrials.gov ID: NCT06754267
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for precursor b-cell acute lymphoblastic leukemia.
Also referred to as Ven.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Before enrollment, the patient must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and positive for Philadelphia chromosome...
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Expected survival time ≥ 3 months;
- No organ dysfunction that would restrict the use of this protocol during the screening period;
You likely can't join if
- Accelerated phase or blast crisis of chronic myeloid leukemia;
- people with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;
- people who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed...
- people with a history of myocardial infarction within 12 months, or have clinical manifestations of heart disease (including but not limited to...
- Diseases with abnormal functions of organs such as lung, liver, and kidney that may limit the patient's participation in this trial (including but...
- History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
See the full eligibility criteria
- Before enrollment, the patient must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and positive for Philadelphia chromosome (presence of t(9;22) and/or BCR::ABL1 positive and/or FISH positive)...
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Expected survival time ≥ 3 months;
- No organ dysfunction that would restrict the use of this protocol during the screening period;
- Understand the study and sign the informed consent form.
- Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed...
- Accelerated phase or blast crisis of chronic myeloid leukemia;
- people with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;
- people who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed pretreatment);
- people with a history of myocardial infarction within 12 months, or have clinical manifestations of heart disease (including but not limited to unstable angina pectoris, congestive heart failure, uncontrolled...
- Diseases with abnormal functions of organs such as lung, liver, and kidney that may limit the patient's participation in this trial (including but not limited to severe infection, uncontrolled diabetes, active...
- History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;
- Known HIV infection;
- Conditions affecting the use of the study drug as assessed by the investigator;
- Unable to understand or comply with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.