Phase II Study of Ponatinib with Mini-hyper CVD Chemotherapy and Venetoclax for Patients with Relapsed or Hard-to-Treat T-cell Acute Lymphoblastic Leukemia
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05268003
This clinical trial is testing a new combination of drugs, including Ponatinib, mini-hyper-CVD chemotherapy, and Venetoclax, to see if it can help patients with T-cell acute lymphoblastic leukemia that has returned or is not responding to treatment achieve complete remission.
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Program Overview
The study aims to find out if adding Ponatinib to a chemotherapy regimen called mini-hyper-CVD, along with Venetoclax, can improve the chances of complete remission in patients with T-cell acute lymphoblastic leukemia that has come back or is not responding to treatment. Researchers will also look at the safety of this treatment combination and how long patients stay in remission, as well as their overall survival.
Description
This study is focused on patients with T-cell acute lymphoblastic leukemia that has either returned after treatment or is not responding to current treatments. The main goal is to see if a combination of Ponatinib, mini-hyper-CVD chemotherapy, and Venetoclax can help these patients achieve complete remission, meaning no signs of cancer.
The study will also evaluate the safety of this drug combination and how long patients remain cancer-free. Researchers will monitor the presence of any remaining cancer cells and track patients' survival rates. Additionally, the study will explore certain biological markers in the cancer cells to understand how the treatment works.
Participants will need to meet specific health criteria to join the study, and they will be closely monitored throughout the treatment process to ensure their safety and to assess the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have T-cell acute lymphoblastic leukemia that has returned or is not responding to treatment.
- Be 12 years or older and weigh more than 40 kg (about 88 pounds).
- Have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
- Have adequate organ function, including:
- Normal bilirubin levels, or slightly higher if you have Gilbert's disease.
- Liver enzymes (ALT and AST) within acceptable limits unless due to the disease.
- Kidney function with creatinine clearance of at least 50 mL/min.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 30 days after the last dose.
- Men with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.
- Must provide written informed consent to participate in the study.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Weigh less than 40 kg (about 88 pounds).
- Have an uncontrolled active infection.
- Have hepatitis B or C, or are HIV positive.
- Have had major surgery or radiation therapy within 4 weeks before starting the study.
- Have received other cancer treatments within 14 days before starting the study, except for certain medications like hydroxyurea or dexamethasone.
- Have signs of pancreatitis, such as high levels of lipase or amylase in the blood.
- Have untreated or symptomatic cancer spread to the brain or spinal cord.
- Have active heart disease or recent heart problems, such as a heart attack or stroke within the last 6 months.
- Have uncontrolled high blood pressure or high triglyceride levels.
- Have another untreated or active cancer.
- Are taking certain medications or supplements that affect liver enzymes or have consumed grapefruit or similar fruits recently.
- Have conditions that prevent taking medications by mouth.
- Have any other severe medical or psychiatric conditions that could interfere with the study.
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