Oral Mucositis
Conditions
Interventions
Trade Name: Kepivance
Product Name: Kepivance
Product Code: ATC V03AF08
Pharmaceutical Form: Powder for solution for injection
Sponsors
Swedish Orphan Biovitrum AB (publ)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ALL or AML requiring HSCT 2. Age = 1 and = 16 years at screening 3. Lansky performance status > 60% 4. Candidate for allogeneic HSCT protocol: • Adequate kidney function: Serum creatinine: = 1.5 mg/dL or creatinine clearance or radioisotope GFR = 60 mL/min/1.73m2 • Adequate liver function: Serum total bilirubin: = 2.0 mg/dl; AST/ALT = 4.0 x institutional upper limits of normal (IULN); Albumin = 2 g/dL • Adequate cardiac function: shortening fraction > 29% documented by echocardiogram, or ejection fraction = 50% documented by multigated acquisition scan (MUGA). • Adequate pulmonary function documented by corrected DLCO > 50% or oxygen saturation of = 92% on room air if unable to perform pulmonary function tests • Negative for human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T cell lymphotropic virus (HTLV) 5. Identification of an HLA-compatible donor per institutional standards 6. Assent from a minor (if the child is capable of giving assent) per Department of Health and Human Services (DHHS) guidelines listed in 21CFR 50.55 and local IRB standards. 7. Serum amylase and lipase: = 1.2 x IULN 8. Negative serum/urine pregnancy test for females with childbearing potential within 4 days before administration of the first palifermin dose 9. Agreement by males and females of reproductive potential to use an effective means of contraception 30 days prior to enrollment through Day +30 (end of treatment) Are the trial subjects under 18? yes Number of subjects for this age range: 54 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
Exclusion criteria: 1. Prior treatment with palifermin or other keratinocyte growth factors 2. Received an investigational product or device, with the exception investigational stem cell separators, in another clinical trial within 30 days before enrollment. 3. Known to have a life threatening infection not responding well to treatment 4. Past history of veno-occlusive disease of the liver 5. Known sensitivity to any Escherichia coli-derived products with grade 3 to 4 allergies to L-asparaginase [grade 1 to 2 allergies to L-asparaginase will be allowed]. 6. Receiving glutamine or any other medication to reduce the incidence of OM within 30 days before enrollment 7. Previous or concurrent malignancy other than entry diagnostic criteria and/or solid organ transplantation and/or treatment of congenital immunodeficiency 8. History of pancreatitis 9. Breastfeeding (giving)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine a safe and tolerable dose of palifermin in pediatric subjects of different age groups when administered once daily for 3 consecutive days before and 3 consecutive days after a myeloablative chemo-radiotherapy conditioning regimen with allogeneic HSCT. ;Secondary Objective: • To define the safety profile of palifermin over a range of doses in pediatric subjects with leukemia undergoing allogeneic HSCT • To characterize the pharmacokinetic (PK) profile of intravenous (IV) bolus injections of palifermin for multiple dose levels in pediatric subjects ;Primary end point(s): Incidence of Dose limiting toxicity;Timepoint(s) of evaluation of this end point: Day -10 to +16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A Incidence and severity of AEs, change in vital signs, and incidence of laboratory abnormalities B PK parameters of palifermin (eg, CL, Vss, t ½z) after the 1st and 3rd IV bolus injection for multiple dose levels C Incidence of serum palifermin antibody formation ;Timepoint(s) of evaluation of this end point: A Day -10 to +16 B After 1st and 3rd bolus dose C Day +30 | — |
Countries
United States
Contacts
Public ContactIda Gunnarsson
Swedish Orphan Biovitrum AB (publ)
Outcome results
None listed