Venetoclax and a Pediatric-Inspired Regimen for Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
Phase 1
24
about 3.9 years
18–54
1 site in CA
What this study is about
This trial is testing the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen called C10403 to treat patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop cancer cells from growing by blocking Bcl-2, a protein needed for survival. The C10403 regimen includes several chemotherapy drugs that work in different ways to kill or prevent the growth of cancer cells, along with prednisone, an anti-inflammatory drug used to lower the body's immune response.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Cyclophosphamide
- 2.Take Cytarabine
- 3.Take Daunorubicin Hydrochloride
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), cytarabine, Antineoplastic Agent [TC] (DNA Polymerase Inhibitors), mercaptopurine, methotrexate, pegaspargase, prednisone, venetoclax
infusion, injection (Injection), oral (Oral Tablet), oral
Primary: Dose limiting toxicity, Incidence of adverse events
Secondary: Complete response (CR) after consolidation, Complete response (CR) after consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Complete response (CR) after induction +/- extended induction, Complete response (CR) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction, Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Overall survival
Oncology