Vyxeos® With Clofarabine for Pediatric AML
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. Relapse treatment generally consists of one course of fludarabine, cytarabine and liposomal daunorubicin (FLAG-DNX), followed by a fludarabine and cyt
| Condition(s) | Relapsed Pediatric AML, Refractory Pediatric AML |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. Relapse treatment generally consists of one course of fludarabine, cytarabine and liposomal daunorubicin (FLAG-DNX), followed by a fludarabine and cytarabine course, and subsequent stem-cell transplantation. Cytarabine has been used in combination with fludarabine and cladribine, with the aim to induce synergism by increasing Ara-CTP (active cytotoxic metabolite from ara-C) accumulation, which can be seen as a surrogate marker for cytarabine induced cell-kill. Synergy with cytarabine can also be achieved with clofarabine, which is a potent inhibitor of ribonucleotide reductase, leading to a depletion of normal deoxynucleot |
| Who can participate | 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 p |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Lead sponsor | Princess Maxima Center for Pediatric Oncology |
| Locations | Vienna, Austria; Copenhagen, Denmark; Augsburg, Germany; Berlin, Germany; Essen, Germany; Frankfurt, Germany (+7 more sites) |
| Start date | 2020-11-06 |
| NCT ID | NCT07156435 |
| Official listing | https://clinicaltrials.gov/study/NCT07156435 |