New treatment option for Ph+ ALL
Official title Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
ClinicalTrials.gov ID: NCT07493161
What this study is testing
What is Olverembatinib?
Olverembatinib is an investigational medicine, being studied as a potential treatment for ph+ all.
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
- This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
- Age ≥ 14 years.
- ECOG performance status ≤ 2.
- Adequate organ function: Total bilirubin \ 45%.
- Male and female patients of childbearing potential must agree to use effective contraception.
You likely can't join if
- Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
- Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or...
- Uncontrolled active severe infection.
- Active psychiatric illness that may hinder treatment completion or informed consent.
- Any other condition deemed unsuitable for the study by the investigator.
See the full eligibility criteria
- Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
- Age ≥ 14 years.
- ECOG performance status ≤ 2.
- Adequate organ function: Total bilirubin \ 45%.
- Male and female patients of childbearing potential must agree to use effective contraception.
- Signed informed consent.
- Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
- Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
- Uncontrolled active severe infection.
- Active psychiatric illness that may hinder treatment completion or informed consent.
- Any other condition deemed unsuitable for the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.