NCT03826992RecruitingPhase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 9 Jan 2019
- Start date
- 27 Dec 2018
- Primary completion date
- Jan 2027
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT03826992
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 27 Dec 2018 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
- Uncontrolled infection
Other
- Pregnant or breastfeeding
- Unable to comply with the safety monitoring requirements of the study
Who the study is looking for
- 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
Age in the registry: 1 year to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.