AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1Ages 1 Year - 39 YearsAllChildren's Hospital Medical Center, Cincinnati
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
๐Ÿ’Š

What it tests

  • Vyxeos
  • Venetoclax
๐Ÿ“

Where

1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy