Testing the Addition of Venetoclax and/or Blinatumomab to Chemotherapy for Infants with Newly Diagnosed Leukemia
Phase 2
153
about 3.6 years
≤0.999336057550805
106 sites in AK, AL, AR +37
What this study is about
Researchers are testing whether adding venetoclax and/or blinatumomab to usual chemotherapy treatment improves outcomes in infants diagnosed with acute lymphoblastic leukemia (ALL) who have a KMT2A gene rearrangement or not. The trial will evaluate the safety and effectiveness of this combination therapy compared to standard chemotherapy alone.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Blinatumomab
- 2.Take Asparaginase Erwinia chrysanthemi
- 3.Take Calaspargase Pegol
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, blinatumomab, calaspargase pegol, cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), cytarabine, daunorubicin, dexamethasone, doxorubicin (Anthracycline chemotherapy; intercalates DNA and inhibits topoisomerase II)
injection (Injection), injection, intravenous, infusion, ocular, oral (Oral Tablet), oral (Disintegrating Oral Tablet), oral
Secondary: 3-year EFS of infants with KMT2A-G ALL treated on Arm C, 3-year EFS of infants with KMT2A-R ALL, Event free survival (EFS) rates of infants with KMT2A-R ALL, Pharmacokinetics (PK) of venetoclax in infants
diagnostic, biopsy, imaging
Oncology