Clinical trial comparing Lipegfilgrastim to Filgrastim in Pediatric PatientsDiagnosed with Ewing Family of Tumors or Rhabdomyosarcoma ReceivingChemotherapy

Phase 1

• Conditions: eutropenia in pediatric patients diagnosed with Ewing family of Tumorsor rhabdomyosarcoma receiving chemotherapy; MedDRA version: 18.0Level: PTClassification code 10029354Term: NeutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 18.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-000087-34-RO
• Lead Sponsor: Merckle GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Study Completion: 2019-01-08
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

a) Male or female children and adolescents aged 2 to <18 years at screening.
b) Written informed consent provided by parent(s)/legal representative(s) of the
pediatric patient and patient’s assent if appropriate, before screening procedures
are initiated.
c) Able to understand and/or follow study instructions alone or with parental
assistance.
d) Diagnosed with the Ewing family of tumors, or rhabdomyosarcoma.
e) Scheduled to receive 1 of the following CTX regimens (inpatient or outpatient):
For the Ewing Family of Tumors:
? VIDE; with concomitant sodium 2-mercaptoethane sulfonate (MESNA)
according to local standards.
? VDC/IE; with concomitant MESNA treatment according to local standards.
For Rhabdomyosarcoma:
? VAC; with concomitant MESNA treatment according to local standards
? VDC/IE; with concomitant MESNA treatment according to local standards.
? IVA; with concomitant MESNA treatment according to local standards.
f) Minimum BW 12.5 kg.
g) Life expectancy of at least 3 months with appropriate therapy
h) WBC count >2.5 × 109/L, ANC =1.5 × 109/L, and platelet count =100 × 109/L (at
screening and prior to CTX)
i) For patients aged =12 years, Eastern Cooperative Oncology Group (ECOG) performance status =2 (see Appendix A).
j) Fertile patients (male or female) must use highly reliable contraceptive measures (ie, 2 of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence) for the entire duration of the study. For purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
k) Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
Are the trial subjects under 18? yes
Number of subjects for this age range: 42
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other granulocyte colony stimulating factors (G-CSFs) / granulocyte macrophage colony-stimulating factors (GM-CSFs) in clinical development within 6 weeks prior to the first lipegfilgrastim/filgrastim
administration in this study.
b. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, any other G-CSF in clinical development or any LONQUEX (lipegfilgrastim) excipients.
c. History of congenital neutropenia or cyclic neutropenia.
d. Patients with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or imaging.
e. Pregnancy or breast feeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
f. Prior bone marrow or stem cell transplant, or prior radiation to =25% of bone marrow (eg, whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the first dose of study drug (lipegfilgrastim/filgrastim).
g. Major surgery or serious infection within 3weeks before first administration of study drug (lipegfilgrastim/filgrastim), serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
h. Treatment with lithium at screening or planned during the study.
i. Participation in a clinical study within 30 days before randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified