Clareo Health | A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
* Adequate liver function: Serum total bilirubin: ≤ 2.0 mg/dl; aspartate transaminase (AST)/alanine aminotransferase (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 lung diffusion capacity test (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 Institutional Review Board (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)
You may not be if
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 oral mucositis (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
