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VyClo ITCC-092
EU CTIS ID: 2023-508050-26-00
What this study is testing
To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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%)
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.