Actively Recruiting
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-02-18
21
Participants Needed
1
Research Sites
470 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.
CONDITIONS
Official Title
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 1 Year to 39 Years
- Diagnosis of acute myeloid leukemia (AML), any subtype except acute promyelocytic leukemia (APML) and myeloid leukemia associated with Down Syndrome (ML-DS)
- Diagnosis of myeloid sarcoma
- Diagnosis of acute leukemia of ambiguous lineage (ALAL), including acute undifferentiated leukemia (AUL), T/myeloid mixed phenotype acute leukemia (MPAL), and B/myeloid MPAL (excluding MPAL with t(9;22))
- Diagnosis of T-cell acute lymphoblastic leukemia (T ALL), early thymocyte precursor (ETP) ALL, or KMT2A-rearranged ALL
- Disease status including relapsed or refractory AML, MPA, and AUL; untreated therapy-related AML; relapsed or refractory KMT2A-rearranged ALL, T-cell ALL, and ETEP ALL
- Karnofsky/Lanksy performance level score of greater than or equal to 50 percent
- Fully recovered from acute toxicities of hematopoietic stem cell transplant (HSCT) or anthracycline exposure
- At least 14 days since completion of systemic cytotoxic therapy other than hydroxyurea, decitabine, or azacitidine
- At least 2 weeks since local palliative radiotherapy; at least 6 months since craniospinal radiotherapy or 50% radiation of pelvis; at least 6 weeks since other substantial bone marrow radiation
- Adequate renal, liver, cardiac, and central nervous system (CNS) function
You will not qualify if you...
- Diagnosis of myeloid leukemia associated with Down Syndrome (ML-DS)
- Diagnosis of acute promyelocytic leukemia (APML)
- Acute leukemia with CNS status 3 involvement
- Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)
- Fanconi anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
- Wilson's disease or other copper-metabolism disorder
- Pregnant or breastfeeding
- Uncontrolled infection
- Received more than 13.6 Gray prior radiation to the mediastinum
- Receipt of growth factors within 7 days prior to enrollment
- Currently receiving another investigational drug
- Currently receiving anti-cancer agents except intrathecal agents or hydroxyurea
- Unable to comply with safety monitoring requirements of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
S
Site Pulblic Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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