News - Kepivance (palifermin)

2ms

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)

P2, N=82, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

2 months ago

Trial completion date • Trial primary completion date

CD34 (CD34 molecule)

Chr t(15;17)

cyclophosphamide • Firmagon (degarelix) • thiotepa • leuprolide acetate for depot suspension • Kepivance (palifermin)

2ms

Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant (clinicaltrials.gov)

P1, N=53, Recruiting, City of Hope Medical Center | Active, not recruiting --> Recruiting | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026

2 months ago

Enrollment open • Trial completion date • Trial primary completion date

HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)

cyclophosphamide • etoposide IV • sirolimus • Kepivance (palifermin)

7ms

Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (clinicaltrials.gov)

P1/2, N=1, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Enrolling by invitation --> Recruiting

7 months ago

Enrollment status

CD40LG (CD40 ligand)

Campath (alemtuzumab) • sirolimus • busulfan • Kepivance (palifermin)

8ms

Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov)

P1/2, N=10, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Suspended --> Recruiting

8 months ago

Enrollment open

busulfan • Kepivance (palifermin) • Neupogen (filgrastim) • plerixafor

8ms

90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)

P1, N=7, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=12 --> 7

8 months ago

Enrollment closed • Enrollment change

FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)

IL2RA expression

melphalan • fludarabine IV • Kepivance (palifermin)

9ms

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov)

P1/2, N=34, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> Mar 2025

9 months ago

Trial completion • Trial completion date

FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • ASXL1 (ASXL Transcriptional Regulator 1) • CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)

Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • sirolimus • Truxima (rituximab-abbs) • fludarabine IV • mesna • Kepivance (palifermin) • Neupogen (filgrastim)

9ms

Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant (clinicaltrials.gov)

P1, N=43, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting

9 months ago

Enrollment closed

HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)

cyclophosphamide • etoposide IV • sirolimus • Kepivance (palifermin)

9ms

Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease (clinicaltrials.gov)

P1/2, N=14, Not yet recruiting, Stanford University

9 months ago

New P1/2 trial

Rituxan (rituximab) • prednisone • clofarabine • melphalan • Kepivance (palifermin)

10ms

Base Editing Hematopoietic Stem Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (clinicaltrials.gov)

P1/2, N=1, Enrolling by invitation, National Institute of Allergy and Infectious Diseases (NIAID)

10 months ago

New P1/2 trial

CD40LG (CD40 ligand)

Campath (alemtuzumab) • sirolimus • busulfan • Kepivance (palifermin)

10ms

Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy (clinicaltrials.gov)

P1/2, N=18, Enrolling by invitation, National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting --> Enrolling by invitation

10 months ago

Enrollment open

busulfan • Kepivance (palifermin) • Neupogen (filgrastim) • plerixafor

10ms

Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy (clinicaltrials.gov)

P1/2, N=18, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Dec 2032 --> Dec 2034 | Trial primary completion date: Dec 2032 --> Dec 2034

10 months ago

Trial completion date • Trial primary completion date

busulfan • Kepivance (palifermin) • Neupogen (filgrastim) • plerixafor

11ms

Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov)

P1/2, N=1, Suspended, National Institute of Allergy and Infectious Diseases (NIAID) | N=10 --> 1

11 months ago

Enrollment change

busulfan • Kepivance (palifermin) • Neupogen (filgrastim) • plerixafor