Status:
RECRUITING
Vyxeos® With Clofarabine for Pediatric AML
Lead Sponsor:
Princess Maxima Center for Pediatric Oncology
Collaborating Sponsors:
Jazz Pharmaceuticals
Conditions:
Relapsed Pediatric AML
Refractory Pediatric AML
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief 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 co...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07156435
Start Date
November 6 2020
End Date
December 31 2028
Last Update
September 5 2025
Active Locations (13)
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1
St. Anna Kinderspital
Vienna, Austria
2
Rigshospitalet
Copenhagen, Denmark
3
Universitätsklinikum Augsburg
Augsburg, Germany
4
Charité Berlin
Berlin, Germany