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New treatment option for Relapsed Pediatric AML
Official title Vyxeos® With Clofarabine for Pediatric AML
ClinicalTrials.gov ID: NCT07156435
What this study is testing
What is Vyxeos 44 MG / 100 MG Liposome Injection?
Vyxeos 44 MG / 100 MG Liposome Injection is an investigational medicine, being studied as a potential treatment for relapsed pediatric aml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Treatment with intensive chemotherapy in AML results in approximately 70% survival in newly diagnosed patients. Prognosis at relapse is worse and is in the 30-40% range.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21
You may be able to join if
- 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
See the full 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Copenhagen, Denmark
- Augsburg, Germany
- Berlin, Germany
- Essen, Germany
- Frankfurt, Germany
- Hamburg, Germany
- Monza, Italy
- Roma, Italy
- Utrecht, Utrecht, Netherlands
- Barcelona, Spain
- Madrid, Spain
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, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Copenhagen, Denmark; Augsburg, Germany; Berlin, Germany; Essen, Germany; Frankfurt, Germany and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.