Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT07156435
Eligibility Criteria:
We will include pediatric patients ≥1 year and ≤21 years with:
* 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 (as defined in Appendix V)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Initial work-up:
• Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy)
General condition:
* Lansky play score ≥ 60 for patients \<16 years of age; or Karnofsky performance status ≥ 60 for patients ≥ 16 years of age (see Appendix I for Performance scales).
* Life expectancy \> 6 weeks
* The patient must have 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%)
* No evidence of a currently uncontrolled bacterial, viral or parasitic infection
* No 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)
* No evidence of isolated extramedullary relapse, including isolated CNS-relapse
* No evidence of CNS3 or symptomatic CNS leukemia
* No Down Syndrome
* No evidence of relapsed/refractory acute promyelocytic leukemia (APL)
* No 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)
* No history of prior veno-occlusive disease (VOD)
* No known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin
* No known copper metabolism deficiency, such as Wilson's disease.
Other:
* For female patients with childbearing potential, a negative test for pregnancy is to be performed before entry on study.
* Male and female patients must use a highly effective contraceptive method according to the CTFG 2014-guidelines during the study and for a minimum of 6 months after study treatment.
NL72866.041.20 / Vyxeos liposomal and Clofarabine in R/R pediatric AML - ITCC-092 Protocol version: 2.2, 08-04-2021 38 of 80
* Female patients may not breast feed during the study and for a minimum of 3 months after study treatment.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule is required; those conditions should be discussed with the patient before registration in the trial.
* Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Concomitant treatments:
* Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed.
* GCSF will not be used for priming and no routine GCSF support is allowed during the 1st course, except for life-threatening infections.
Additional criteria:
• At least 6 patients must be enrolled with an M3 or a WBC count \>10x109/L with blasts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT07156435
Study Brief:
Protocol Section:
NCT07156435