VyClo ITCC-092
Key facts
- Where
- Augsburg, Berlin, Essen, Frankfurt Am Main és Hamburg, NémetországSee the 5 sites
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What type of cancer has the patient been diagnosed with?
- Has the patient had Down syndrome (an extra copy of chromosome 21) diagnosed?
Where in Németország
- Universitaetsklinikum AugsburgAugsburg, NémetországTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Trial code
- EU 2023-508050-26-00
- Record updated
- 2025. október 21.
- Original description
To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML.Read full original descriptionShow less
A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML
To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML.
Inclusion: Any ≥ 2nd relapse of AML • Refractory AML (defined as ≥ 20% blasts in the bone marrow after standard (re-) induction therapy) • Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML • Any relapse of AML after prior allogenic HSCT • Any relapse of AML with high risk cytogenetic characteristics • Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy) • Lansky play score ≥ 60 for patients <16 years of age; or Karnofsky performance status ≥ 60 for patients ≥ 16 years of age • Life expectancy > 6 weeks • a calculated GFR ≥ 70mL/min/1.73 m2 • Liver function: total serum bilirubin ≤ 3 mg/dl or 50 µmol/L and aspartate transaminase (AST) and alanine transaminase (ALT) ≤200 U/L • Adequate cardiac function (defined as shortening fraction ≥28% or ejection fraction ≥50%).
Exclusion: evidence of a currently uncontrolled bacterial, viral or parasitic infection • evidence of a fungal infection, defined as either: - Pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment) - Positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment) • evidence of isolated extramedullary relapse, including isolated CNS-relapse • evidence of CNS3 or symptomatic CNS leukemia • Down Syndrome • evidence of relapsed/refractory acute promyelocytic leukemia (APL) • use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia) • history of prior veno-occlusive disease (VOD) • known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin • known copper metabolism deficiency, such as Wilson's disease.