Clinical trial comparing Lipegfilgrastim to Filgrastim in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy.

Phase 1

• Conditions: eutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy; MedDRA version: 18.1Level: PTClassification code 10029354Term: NeutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 18.1Level: 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-DE
• Lead Sponsor: Merckle GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• 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:
- Vincristine/Ifosfamide/Doxorubicin/Etoposide (VIDE); with concomitant sodium 2-mercaptoethane sulfonate (MESNA) according to local standards.
- Vincristine/Doxorubicin/Cyclophosphamide alternating with Ifosfamide/Etoposide (VDC/IE); with concomitant MESNA treatment according to local standards.
For Rhabdomyosarcoma:
- Vincristine/Actinomycin/Cyclophosphamide (VAC); with concomitant MESNA treatment according to local standards.
- VDC/IE; with concomitant MESNA treatment according to local standards.
- Ifosfamide, Vincristine, and Actinomycin D (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. White blood cell (WBC) count >2.5 × 10^9/L, absolute neutrophil count (ANC) =1.5 × 10^9/L, and platelet count =100 × 10^9/L (at screening and prior to CTX).
i. For patients aged =12 years, Eastern Cooperative Oncology Group (ECOG) performance status =2.
j. Fertile patients (male or female) must use highly reliable contraceptive measures for the entire duration of the study.
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