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Taking people in DenmarkPhase 1

Tests Vyxeos with clofarabine in children with relapsed or refractory acute myeloid leukemia

Tests Vyxeos plus clofarabine to find a dose in children with returning acute myeloid leukemia.

Key facts

Who runs it
Prinses Maxima Centrum voor Kinderoncologie B.V.
Where
Copenhagen Oe, DenmarkSee the siteAlso in 5 other countries, 12 sites
Registry title
VyClo ITCC-092
Status
Recruiting
Phase
Phase 1
People taking part
25 people, planned
Started
17 Jul 2025
Expected to end
1 Dec 2028
Type of study
Interventional
Record updated
21 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with acute myeloid leukaemia (AML) that has come back or has not responded to treatment.

Age
Up to 64 years.
Sex
All sexes can join.
Disease stage
AML that has relapsed a second time or more, is refractory (20% or more blasts in the bone marrow after standard treatment), relapsed within one year of diagnosis, relapsed after a donor stem-cell transplant (allogenic HSCT), or relapsed with high-risk cytogenetic features.
Earlier treatment
No anticancer therapy within 2 weeks before study entry. Recovery from all acute side effects of earlier treatment is needed. A history of veno-occlusive disease (VOD) is not allowed.

Main reasons for not taking part

  • Uncontrolled bacterial, viral or parasitic infection, or a fungal infection
  • Leukaemia only outside the bone marrow, including only in the central nervous system (CNS), or CNS3 or symptomatic CNS leukaemia
  • Down syndrome
  • Acute promyelocytic leukaemia (APL)
  • Known allergy to cytarabine, clofarabine or liposomal daunorubicin, or a copper metabolism problem such as Wilson's disease

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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%)

Who cannot take part

  • 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

Check if you might fit

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 Denmark

Also in 5 other countries, 12 sites

  • RigshospitaletCopenhagen Oe, DenmarkTaking people

About the trial

What the trial wants to find out

To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML
Plain-language title
Tests Vyxeos with clofarabine in children with relapsed or refractory acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2023-508050-26-00, who can take part
Record updated
21 October 2025