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218 Diseases |  |
9 Trials |
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9 Trials |  |
242 News |  |
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- | Kepivance (palifermin) / SOBI, Amgen, Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment status: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov) - Apr 30, 2024
P1/2, N=10, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrolling by invitation --> Recruiting
- ||| Kepivance (palifermin) / SOBI, Amgen, avasopasem manganese (GC4419) / Galera Therap, dusquetide (SGX942) / Soligenix
Clinical, P3 data, Journal: Comparisons of successful and failed Phase III trials of drugs and biologicals tested for mitigation of oral mucositis in patients being treated with radiotherapy with or without concomitant chemotherapy for cancers of the head and neck. (Pubmed Central) - Apr 28, 2024
We found that differences in the level of sponsor funding, patient inclusion criteria including radiation source and concomitant chemotherapy regimen, and concordance of primary efficacy outcomes between Phase II and Phase III trials influenced outcomes. To properly design clinical trials for OM in HNC patients, it is important that researchers and sponsors take note of specific study characteristics associated with success or failure, particularly with Phase III trials where the risks and costs are the highest.
- || Kepivance (palifermin) / SOBI, Amgen
Review, Journal: Oral Mucositis Management in Children under Cancer Treatment: A Systematic Review. (Pubmed Central) - Apr 27, 2024
Low-level laser therapy, palifermin, honey, and zinc demonstrated reductions in oral mucositis incidence, duration, severity, and pain reported by the patient. Although there are several therapies in place for the prevention and treatment of oral mucositis in children, evidence of their efficacy is still inconclusive to establish accurate clinical protocols.
- | Kepivance (palifermin) / SOBI, Amgen, Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment open: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov) - Apr 5, 2024
P1/2, N=10, Enrolling by invitation, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Although there are several therapies in place for the prevention and treatment of oral mucositis in children, evidence of their efficacy is still inconclusive to establish accurate clinical protocols. Not yet recruiting --> Enrolling by invitation
- | Kepivance (palifermin) / SOBI, Amgen, Neupogen (filgrastim) / Kyowa Kirin, Amgen
New P1/2 trial: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov) - Mar 22, 2024
P1/2, N=10, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- | Kepivance (palifermin) / SOBI, Amgen, MB-207 / Fortress
Trial completion date, Trial primary completion date: Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (clinicaltrials.gov) - Mar 12, 2024
P1/2, N=40, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Enrolling by invitation Trial completion date: Dec 2024 --> Dec 2032 | Trial primary completion date: Dec 2024 --> Dec 2032
- | Simulect (basiliximab) / Novartis
Trial completion date, Trial primary completion date: 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) - Jan 29, 2024
P1, N=12, Recruiting, Sponsor: City of Hope Medical Center
Trial completion date: Dec 2024 --> Dec 2032 | Trial primary completion date: Dec 2024 --> Dec 2032 Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Feb 2024 --> Dec 2024
- | Kepivance (palifermin) / SOBI, Amgen, MB-207 / Fortress
Enrollment change: Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (clinicaltrials.gov) - Jan 28, 2024
P1/2, N=40, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Feb 2024 --> Dec 2024 N=30 --> 40
- | Kepivance (palifermin) / SOBI, Amgen, MB-207 / Fortress
Enrollment open, Enrollment change: Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (clinicaltrials.gov) - Jan 23, 2024
P1/2, N=30, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=30 --> 40 Suspended --> Recruiting | N=19 --> 30
- | Kepivance (palifermin) / SOBI, Amgen
Trial completion date, Trial primary completion date: Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - Jan 17, 2024
P1/2, N=50, Recruiting, Sponsor: National Cancer Institute (NCI)
Suspended --> Recruiting | N=19 --> 30 Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
- || Kepivance (palifermin) / SOBI, Amgen, Firmagon (degarelix) / Astellas, Ferring
Trial completion date, Trial primary completion date: 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) - Jan 4, 2024
P2, N=82, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- | Rituxan (rituximab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: UKALL14: Standard Chemotherapy With or Without Nelarabine or Rituximab in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Nov 29, 2023
P3, N=1033, Active, not recruiting, Sponsor: University College, London
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- | Kepivance (palifermin) / SOBI, Amgen
Journal: Palifermin-Associated Cutaneous Papular Rash of the Head and Neck. (Pubmed Central) - Nov 3, 2023
Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 No abstract available
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Kepivance (palifermin) / SOBI, Amgen
Addition of Myeloablative Doses of Total Marrow Irradiation (TMI) to Myeloablative Fludarabine/Busulfan Conditioning for Allogeneic HSCT in Patients with High-Risk AML, CML, or Myelodysplast... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6357;
P2
Graft-versus-host disease (GVHD) prophylaxis was with methotrexate and tacrolimus, and palifermin was used to prevent severe mucositis...Kaplan Meyer curves for Overall Survival (OS) and DFS are shown in Figure 1 and 2, respectively. Addition of myeloablative TMI at 9Gy to standard myeloablative targeted FluBu4 was well tolerated and achieved very encouraging results in a group of patients with myeloid malignancies at high risk of relapse (clinicaltrials.gov Identifier: NCT03121014).
- Kepivance (palifermin) / SOBI, Amgen
Preconditioning Single High-Dose Palifermin Alters the Posttransplant Inflammatory Cytokine Profile (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6243;
P1/2, P2
Addition of myeloablative TMI at 9Gy to standard myeloablative targeted FluBu4 was well tolerated and achieved very encouraging results in a group of patients with myeloid malignancies at high risk of relapse (clinicaltrials.gov Identifier: NCT03121014). This trial evaluates the incidence of severe CGVHD (primary objective of phase 2) following the addition of a single high dose of palifermin to GVHD prophylaxis with TMS (tacrolimus, methotrexate, sirolimus)...All patients received cyclophosphamide (total 4.8 g/m 2 ) and fludarabine (total 120 mg/m 2 ) as conditioning on days -6 to -3 followed by infusion of an 8/8 HLA-matched unrelated donor peripheral blood cell graft on day 0...The administration of a single high dose of palifermin (KGF) prior to conditioning treatment resulted in a notably distinct cytokine profile, characterized by a reduction in several GVHD associated pro-inflammatory cytokines, consistent with KGF
- | Kepivance (palifermin) / SOBI, Amgen
Journal: Temporal variation in oral microbiome composition of patients undergoing autologous hematopoietic cell transplantation with keratinocyte growth factor. (Pubmed Central) - Sep 13, 2023
Results of this pilot study suggest treatment with AHCT and palifermin affects the oral microbiome, resulting in temporal shifts in oral microbial community composition. Future studies are warranted to confirm these trends and further investigate the effects of AHCT on the oral microbiome and how these shifts may affect health outcomes.
- | Kepivance (palifermin) / SOBI, Amgen
Enrollment open, Enrollment change: Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - Jul 5, 2023
P1/2, N=50, Recruiting, Sponsor: National Cancer Institute (NCI)
Future studies are warranted to confirm these trends and further investigate the effects of AHCT on the oral microbiome and how these shifts may affect health outcomes. Suspended --> Recruiting | N=32 --> 50
- | fludarabine IV / Generic mfg., thiotepa / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov) - Jun 6, 2023
P2, N=40, Active, not recruiting, Sponsor: Case Comprehensive Cancer Center
Suspended --> Recruiting | N=32 --> 50 Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2023
- | Kepivance (palifermin) / SOBI, Amgen
Enrollment change, Trial suspension: Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - Jun 1, 2023
P1/2, N=32, Suspended, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2023 N=50 --> 32 | Recruiting --> Suspended
- melphalan / Generic mfg.
PROTRACTED DIARRHEA FROM HIGH-DOSE MELPHALAN IN AUTOLOGOUS HEMATOPOIETIC TRANSPLANTATION: RESPONSE TO SHORT COURSE OF ORAL BUDESONIDE () - May 12, 2023 - Abstract #EHA2023EHA_3222;
We do not think these diarrheas were related to autologous graft versus host disease. We did not observe any untoward effects of such short courses of BUD.
- Kepivance (palifermin) / SOBI, Amgen
Study for the prevention of oral mucositis. (On Demand | Hall A; Poster Bd # 511a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3743;
P1/2
Current clinical guidelines recommend prophylactic oral care, cryotherapy, KGF-1, palifermin, and photobiomodulation to prevent OM in specific patient groups...Forty-two patients have already completed the study, while the enrollment of other participants continues and is planned to be completed by the end of 2023. Clinical trial information: NCT05338398.
- Kepivance (palifermin) / SOBI, Amgen
Busulfan, melphalan, and carfilzomib (BuMelCar) conditioning for autologous stem cell transplant (ASCT) in multiple myeloma: Phase I/II data. (On Demand | Hall A; Poster Bd # 13) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1379;
P1/2
A comparison study with mel 200 is warranted to test whether BuMelCar can improve transplant outcomes especially in high-risk patients. Clinical trial information: NCT03795597.
- | idraparinux sodium (SANORG 34006) / Sanofi, Kepivance (palifermin) / SOBI, Amgen
Journal: Interactions of heparin derivatives with recombinant human keratinocyte growth factor: structural stability and bioactivity effect study. (Pubmed Central) - Mar 9, 2023
The result showed that rhKGF-Idraparinux (-6.9 kcal/mol) and rhKGF-Heparin (-6.0 kcal/mol) complexes had significant binding affinity as well as they had a more stable binding to rhKGF than to other LMWH during 100 ns simulation. However, in order to confirm the curative effect of these drugs, clinical trials must be done.
- | Kepivance (palifermin) / SOBI, Amgen
Journal: Rational Design and Production of Bioactive Analogs of Recombinant Human Keratinocyte Growth Factor (rhKGF) with Reduced Aggregation Propensity. (Pubmed Central) - Mar 2, 2023
All of the mutants were at least as potent as rhKGF in stimulating proliferation of MCF-7 epithelial cells. Our results identified A51E as an equally potent, more stable, and less aggregation-prone analog of rhKGF which could be a promising alternative drug candidate for the commercially available rhKGF (Palifermin).
- | fludarabine IV / Generic mfg., thiotepa / Generic mfg.
Trial completion date, Trial primary completion date: Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov) - Feb 8, 2023
P2, N=39, Recruiting, Sponsor: Case Comprehensive Cancer Center
Our results identified A51E as an equally potent, more stable, and less aggregation-prone analog of rhKGF which could be a promising alternative drug candidate for the commercially available rhKGF (Palifermin). Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Jun 2023
- || Kepivance (palifermin) / SOBI, Amgen
Review, Journal: Interventions for the Prevention of Oral Mucositis in Patients Receiving Cancer Treatment: Evidence from Randomised Controlled Trials. (Pubmed Central) - Jan 21, 2023
Allopurinol was potentially effective in the prevention of radiotherapy-induced oral mucositis; antimicrobial mouthwash and erythropoietin mouthwash were associated with a lower risk of development of severe oral mucositis induced by chemotherapy. The results of our review may assist in highlighting the efficacy and testing the effectiveness of low-cost, safe preventative measures for oral mucositis in cancer patients.
- | Simulect (basiliximab) / Novartis
Trial completion date, Trial primary completion date: 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) - Jan 17, 2023
P1, N=12, Recruiting, Sponsor: City of Hope Medical Center
The results of our review may assist in highlighting the efficacy and testing the effectiveness of low-cost, safe preventative measures for oral mucositis in cancer patients. Trial completion date: Jul 2024 --> Feb 2024 | Trial primary completion date: Jul 2024 --> Feb 2024
- Kepivance (palifermin) / SOBI, Amgen
Phase 2 Study of Single High-Dose Palifermin for Graft-Versus-Host Disease Prevention after Matched Unrelated Donor Transplantation () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_988;
P1/2, P2
Methods All patients received cyclophosphamide and fludarabine as reduced intensity conditioning followed by infusion of an 8/8 HLA-matched unrelated donor (MUD) peripheral blood stem cell graft (Figure 1)...Conclusion Palifermin administration at single high-doses of 540 or 720 µg/kg prior to transplant conditioning resulted in a low incidence of aGVHD II-IV but had no impact on severe cGVHD. The observed low incidence of aGVHD could be ascribed to cytoprotective and anti-inflammatory effects of palifermin and should be further investigated.
- Kepivance (palifermin) / SOBI, Amgen
Outcomes of Pediatric Bone Marrow Transplant Patients Receiving Palifermin with Melphalan-Based Conditioning Regimens () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_792;
MBI-CLABSI rates appeared similar between the groups. Further analyses of these findings with multivariable analyses and proper confounding control are ongoing to better characterize the relationship between palifermin, mucositis, and clinical outcomes.
- melphalan / Generic mfg.
Protracted Diarrhea from High-Dose Melphalan in Autologous Hematopoietic Transplantation: Response to Short Course of Oral Budesonide () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_790;
While newer melphalan preparations are available and prevention of melphalan induced GI toxicity is being studied (Uproleselan), a short course of oral budesonide provided rapid resolution and facilitated patient discharge. Oral BUD results in rapid resolution of lower GI toxicity of HDM and potentially lowers cost of hospitalization.
- || Kepivance (palifermin) / SOBI, Amgen
Review, Journal: Noninvasive Systemic Modalities for Prevention of Head and Neck Radiation-Associated Soft Tissue Injury: A Narrative Review. (Pubmed Central) - Oct 6, 2022
Oral BUD results in rapid resolution of lower GI toxicity of HDM and potentially lowers cost of hospitalization. While we cannot endorse any of these nine modalities for immediate clinical use, they may prove fruitful areas for further investigation.
- | melphalan / Generic mfg., budesonide / Generic mfg.
Journal: CT-207 Protracted Diarrhea from High-Dose Melphalan in Autologous Hematopoietic Transplantation: Response to Short Course of Oral Budesonide. (Pubmed Central) - Sep 29, 2022
While newer melphalan preparations are available and prevention of melphalan-induced GI toxicity is being studied (Uproleselan), a short course of oral budesonide provided rapid resolution and facilitated patient discharge. Oral BUD results in rapid resolution of lower GI toxicity of HDM and potentially lowers the cost of hospitalization.
- melphalan / Generic mfg.
Protracted Diarrhea from High- Dose Melphalan in Autologous Hematopoietic Transplantation: Response to Short Course of Oral Budesonide () - Sep 22, 2022 - Abstract #SOHO2022SOHO_863;
While newer melphalan preparations are available and prevention of melphalan-induced GI toxicity is being studied (Uproleselan), a short course of oral budesonide provided rapid resolution and facilitated patient discharge. Oral BUD results in rapid resolution of lower GI toxicity of HDM and potentially lowers the cost of hospitalization.
- | Kepivance (palifermin) / SOBI, Amgen
Journal: Palifermin, administered for three doses only, reduces mucositis in patients undergoing HSCT and receiving chemoradiotherapy conditioning. (Pubmed Central) - Aug 10, 2022
Oral BUD results in rapid resolution of lower GI toxicity of HDM and potentially lowers the cost of hospitalization. No abstract available
- | Kepivance (palifermin) / SOBI, Amgen, MB-207 / Fortress
Enrollment change, Trial suspension: Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (clinicaltrials.gov) - May 18, 2022
P1/2, N=19, Suspended, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No abstract available N=30 --> 19 | Recruiting --> Suspended
- Kepivance (palifermin) / SOBI, Amgen
PALIFERMIN AS SECONDARY PROPHYLAXIS FOR CHEMOTHERAPY INDUCED MUCOSITIS: A RETROSPECTIVE EXPERIENCE () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_318;
In addition, group B had a high rate of severe mucositis (50%) following COPADM2. Two patients received palifermin prior to COPADM2, and neither had severe mucositis after this chemotherapy, suggesting some efficacy in preventing severe mucositis for this subset of patients.
- || Kepivance (palifermin) / SOBI, Amgen
Retrospective data, Review, Journal: A meta-analysis of palifermin efficacy for the management of oral mucositis in patients with solid tumours and haematological malignancy. (Pubmed Central) - Apr 6, 2022
Two patients received palifermin prior to COPADM2, and neither had severe mucositis after this chemotherapy, suggesting some efficacy in preventing severe mucositis for this subset of patients. Palifermin reduces the incidence of severe mucositis up to 30 % in patients receiving treatment with chemotherapy and/or radiotherapy.
- || Kepivance (palifermin) / SOBI, Amgen
Clinical, Journal: Palifermin as primary mucositis prophylaxis in patients with B-cell Non-Hodgkin lymphoma: a case series. (Pubmed Central) - Mar 3, 2022
Palifermin reduces the incidence of severe mucositis up to 30 % in patients receiving treatment with chemotherapy and/or radiotherapy. No abstract available
- | Simulect (basiliximab) / Novartis
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: 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) - Feb 17, 2022
P1, N=12, Recruiting, Sponsor: City of Hope Medical Center
No abstract available Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Jul 2024 | Initiation date: Dec 2021 --> Jul 2024 | Trial primary completion date: Jun 2023 --> Jul 2024
- | fludarabine IV / Generic mfg., thiotepa / Generic mfg.
Trial completion date, Trial primary completion date: Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov) - Jan 25, 2022
P2, N=39, Recruiting, Sponsor: Case Comprehensive Cancer Center
Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Jul 2024 | Initiation date: Dec 2021 --> Jul 2024 | Trial primary completion date: Jun 2023 --> Jul 2024 Trial completion date: Jan 2022 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023
- || Kepivance (palifermin) / SOBI, Amgen
Review, Journal: Keratinocyte growth factor in focus: A comprehensive review from structural and functional aspects to therapeutic applications of palifermin. (Pubmed Central) - Dec 30, 2021
Hence, a growing number of ongoing researches are designed to deal with these problems and enhance the physicochemical and pharmaceutical properties of palifermin. In the current review, we discuss KGF structure and function, potential therapeutic applications of palifermin, as well as the latest progress in the production of recombinant human KGF and its challenges ahead.
- | Simulect (basiliximab) / Novartis
New P1 trial: 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) - Nov 30, 2021
P1, N=12, Not yet recruiting, Sponsor: City of Hope Medical Center
- ||| Kepivance (palifermin) / SOBI, Amgen
Clinical, Clinical guideline, Review, Journal: Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in pediatric cancer and hematopoietic stem cell transplant patients: 2021 update. (Pubmed Central) - Nov 21, 2021
Intraoral photobiomodulation therapy (620-750 nm spectrum) should be used in pediatric patients undergoing autologous or allogeneic HSCT and for pediatric head and neck carcinoma patients undergoing radiotherapy. Palifermin should not be used routinely in pediatric cancer or HSCT patients.
- || Kepivance (palifermin) / SOBI, Amgen
Clinical, Journal: A prospective cohort study comparing long-term outcomes with and without palifermin in patients receiving hematopoietic cell transplantation for hematologic malignancies. (Pubmed Central) - Oct 22, 2021
This long-term prospective safety cohort study demonstrated that the KGF group had no increased risk of overall mortality, relapse, new malignancies, or any other key outcome. The broad inclusion criteria allow the results to be generalized to contemporary practice for patients with a wide range of diseases and receiving a wide range of HCT conditioning regimens and graft sources from diverse donor types.
- | Kepivance (palifermin) / SOBI, Amgen
Trial completion date, Trial primary completion date: Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - Sep 14, 2021
P1/2, N=50, Recruiting, Sponsor: National Cancer Institute (NCI)
The broad inclusion criteria allow the results to be generalized to contemporary practice for patients with a wide range of diseases and receiving a wide range of HCT conditioning regimens and graft sources from diverse donor types. Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- Kepivance (palifermin) / SOBI, Amgen, Noxafil (posaconazole) / Merck (MSD)
[VIRTUAL] Oral Manifestations and Complications in Pediatric Leukemic Patient and Its Management () - Sep 12, 2021 - Abstract #ICBMT2021ICBMT_250;
Periodontal debridement (scaling and root planning) with antibiotics prophylaxis and daily rinsing with 0.1-0.2% chlorhexidine gluconate is recommended to minimize oral complications during remission-induction chemotherapy. Parents need to be educated about benefits of optimal oral hygiene for their children and need to seek immediate care for mouth pain and lesions.
- | Campath (alemtuzumab) / Sanofi, Kepivance (palifermin) / SOBI, Amgen
Enrollment change, Trial termination: Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Aug 17, 2021
P1, N=3, Terminated, Sponsor: Columbia University
Parents need to be educated about benefits of optimal oral hygiene for their children and need to seek immediate care for mouth pain and lesions. N=20 --> 3 | Active, not recruiting --> Terminated
- | Kepivance (palifermin) / SOBI, Amgen
Enrollment open, Trial completion date, Trial primary completion date: 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) - Aug 11, 2021
P1, N=36, Recruiting, Sponsor: City of Hope Medical Center
N=20 --> 3 | Active, not recruiting --> Terminated Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||||| Kepivance (palifermin) / SOBI, Amgen
Clinical: A prospective cohort study comparing long-term outcomes with and without palifermin in patients receiving #BMTsm for hematologic malignancies @ASTCT_Journal @bmtdata @CIBMTR https://t.co/WparQ58Pw0 (Twitter) - Jul 4, 2021
- || Kepivance (palifermin) / SOBI, Amgen
Clinical, Journal: Effect of Keratinocyte Growth Factor on Hospital Readmission and Regimen-Related Toxicities after Autologous Hematopoietic Cell Transplantation for Lymphoma. (Pubmed Central) - Jul 4, 2021
The addition of palifermin limits severe regimen-related toxicities and decreases readmissions and duration of hospital stay. This and other measures are needed to identify comprehensive and cost-effective approaches, possibly including palifermin, to prevent severe regimen-related toxicities and decrease health care resource utilization.