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Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

{ "Venetoclax Combined With Vyxeos for Relapsed or Refractory Acute Leukemia", "This study is looking at combining two medicines, Venetoclax and Vyxeos (CPX-351), for children and young adults (ages 1 to 39) with acute leukemia that has come back or not responded to previous treatments. The main goal is to see if this combination is safe and how well people tolerate it. Researchers will also look at how many people respond to the treatment. You would receive a single course of study therapy, including daily Venetoclax and Vyxeos given on specific days. The study is currently recruiting about 21 participants.", "design": "This is a single-institution Phase I pilot study, which means it's an early-stage study testing safety and tolerability in a small group of participants.", "commitments": "You would receive a single course of study therapy, consisting of daily Venetoclax and Vyxeos given intravenously on Days 1, 3, and 5.", "compensation": "Not stated in the trial record.", "follow_up": "The study will look at treatment-related toxicities for up to 60 days after treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03826992

Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

Recruiting
PHASE1Ages 1–39InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~21 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:VyxeosVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities)
Measured over 28 days
+1 more outcome measured

Conditions

Leukemia

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Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • John Perentesis, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Site Pulblic Contact
[email protected]
513-636-2799
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 1 Year to 39 Years
Diagnosis of one of the following:
Acute myeloid leukemia (AML), any subtype except
Patients with acute promyelocytic leukemia (APML) are NOT eligible
Patients with ML-DS are NOT eligible
Myeloid sarcoma
Acute leukemia of ambiguous lineage (ALAL)
Acute undifferentiated leukemia (AUL)
T/myeloid mixed phenotype acute leukemia (MPAL)
B/myeloid MPAL
MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible
T-cell acute lymphoblastic leukemia (T ALL)
Early thymocyte precursor (ETP) ALL
KMT2A-rearranged ALL
Disease Status
Relapsed/Refractory AML, MPA, and AUL
Untreated therapy related AML
Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL
Karnofsky/Lanksy performance level score of greater than or equal to 50 percent.
Prior therapy requirements
Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure
14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine
2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation
Adequate renal, liver, cardiac, and central nervous system (CNS) function

Exclusion

Diagnosis of one of the following:
Myeloid Leukemia associated with Down Syndrome (ML-DS)
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 greater than 13.6 Gray (Gy) 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 (with the exception of intrathecal (IT) agents or hydroxyurea)
Unable to comply with the safety monitoring requirements of the study

What this trial measures

  • Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities)28 days

    If 2 or more participants have dose limiting toxicities at a given dose level, the maximum tolerated dose will have been exceeded.

  • Treatment related toxicities60 days

    Number of related adverse events