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- || Zarzio (filgrastim biosimilar) / Novartis
Clinical, Reimbursement, Journal, Medicare: Biosimilar Uptake in Medicare Part B Varied Across Hospital Outpatient Departments and Physician Practices: The Case of Filgrastim. (Pubmed Central) - Aug 12, 2020
Our findings indicated that physician practices and hospital outpatient departments have distinctive biosimilar uptake patterns. Thus policy makers aiming to contain Medicare Part B spending might consider focusing on incentivizing biosimilar uptake among hospital outpatient departments.
- | Mozobil (plerixafor) / Sanofi, Zarzio (filgrastim biosimilar) / Novartis
Retrospective data, Journal: Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Transplantation Seems Less Efficacious in Poor Mobilizers with the Use of a Biosimilar of Filgrastim and Plerixafor: A Retrospective Comparative Analysis. (Pubmed Central) - Jul 24, 2020
Thus policy makers aiming to contain Medicare Part B spending might consider focusing on incentivizing biosimilar uptake among hospital outpatient departments. The study revealed that BIO had a lower efficacy for stem cell mobilization when the only treatment was G-CSF, especially in poor mobilizers needing PLEX.
- Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] LEUKOCYTAPHERESIS - ONE TECHNIQUE, DIVERSE OPPORTUNITIES IN THE THERAPY OF PATIENTS (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_5858;
We obtained the sufficient numbers of MNC, CD 3+ and CD 34+ cells for therapy of the patients. Percentage of MNC in the products was in non-mobilized patients and donors higher than in mobilized PBPC donors.
- Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] LEUKOCYTAPHERESIS - ONE TECHNIQUE, DIVERSE OPPORTUNITIES IN THE THERAPY OF PATIENTS (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_5857;
We obtained the sufficient numbers of MNC, CD 3+ and CD 34+ cells for therapy of the patients. Percentage of MNC in the products was in non-mobilized patients and donors higher than in mobilized PBPC donors.
- || Clinical, Journal: Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma. (Pubmed Central) - Jul 2, 2020
In this simulation, the incremental costs of FN-related hospitalization due to PEG-OBI failure in cycle 1 compared to assured prophylaxis with reference pegfilgrastim, reference filgrastim, and biosimilar filgrastim-sndz varied depending upon the PEG-OBI failure rate and the alternative G-CSF prophylaxis option. Biosimilar filgrastim-sndz offers the greatest cost-efficiency.
- Neupogen (filgrastim) / Kyowa Hakko Kirin, Roche, Amgen, Zarzio (filgrastim biosimilar) / Novartis, paclitaxel / Generic mfg.
[VIRTUAL] Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile neutropenia (FN) in non-small cell lung cancer (NSCLC) patients at intermediate risk. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5110;
For NSCLC patients at intermediate risk of FN receiving adjuvant carboplatin/paclitaxel with 1+RF, PP with filgrastim-sndz compared to SP is cost-effective based on a WTP threshold of $50,000/QALY. Research Funding: Sandoz, Inc.
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Mar 24, 2020
P1/2, N=21, Terminated, Sponsor: M.D. Anderson Cancer Center
Research Funding: Sandoz, Inc. N=55 --> 21 | Trial completion date: Mar 2021 --> Mar 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2021 --> Mar 2020; Per PI at time of CR
- Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] LEUKOCYTAPHERESIS - ONE TECHNIQUE, DIVERSE OPPORTUNITIES IN THE THERAPY OF PATIENTS (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_2364;
We obtained the sufficient numbers of MNC, CD 3+ and CD 34+ cells for therapy of the patients. Percentage of MNC in the products was in non-mobilized patients and donors higher than in mobilized PBPC donors.
- | Jakafi oral (ruxolitinib) / Novartis, Incyte, Zarzio (filgrastim biosimilar) / Novartis
Journal: Targeting Financial Toxicity in Oncology Specialty Pharmacy at a Large Tertiary Academic Medical Center. (Pubmed Central) - Nov 29, 2019
Percentage of MNC in the products was in non-mobilized patients and donors higher than in mobilized PBPC donors. This project demonstrates the importance of an oncology specialty pharmacy team in ensuring timely approval of a foundation grant and reducing financial toxicity, which can play a major role in access to therapy.
- | Zarzio (filgrastim biosimilar) / Novartis
Clinical, P3 data, Journal: Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies. (Pubmed Central) - Oct 10, 2019
This combined analysis of two phase III studies provides additional clinical evidence that the biosimilar filgrastim EP2006 has a safety profile consistent with previous studies of reference filgrastim and supports large postmarketing studies of EP2006 in Europe. Strengthening the evidence for biosimilar filgrastim can help improve acceptance of biosimilars and increase patient access to biologics.
- | Zarzio (filgrastim biosimilar) / Novartis
Journal: Re: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. (Pubmed Central) - Sep 1, 2019
Strengthening the evidence for biosimilar filgrastim can help improve acceptance of biosimilars and increase patient access to biologics. No abstract available
- | Zarzio (filgrastim biosimilar) / Novartis
Journal: Reply: Re: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. (Pubmed Central) - Sep 1, 2019
No abstract available No abstract available
- || Zarzio (filgrastim biosimilar) / Novartis
Clinical: Nice work! intriguing case is #Zarxio which has >50% market share (Twitter) - Jul 16, 2019
- | Zarzio (filgrastim biosimilar) / Novartis
Journal: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product. (Pubmed Central) - Jul 4, 2019
No abstract available Except for the deviating specific activities of the two copy filgrastim products, we found no substantial differences in product quality between the filgrastim products studied.
- | Zarzio (filgrastim biosimilar) / Novartis
Journal: Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated "same-day" ( 72 h): findings from the MONITOR-GCSF study. (Pubmed Central) - Jun 23, 2019
This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24-72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment change: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jun 17, 2019
P1/2, N=44, Recruiting, Sponsor: M.D. Anderson Cancer Center
Filgrastim administration on the day of chemotherapy may be appropriate in some patients. N=22 --> 44
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Trial completion date: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jun 4, 2019
P1/2, N=22, Recruiting, Sponsor: M.D. Anderson Cancer Center
N=22 --> 44 Trial completion date: May 2020 --> May 2021
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment change: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - May 15, 2019
P1/2, N=22, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: May 2020 --> May 2021 N=44 --> 22
- | Zarzio (filgrastim biosimilar) / Novartis
Clinical, Journal, HEOR: Patient-Administered Biologic and Biosimilar Filgrastim May Offer More Affordable Options for Patients with Nonmyeloid Malignancies Receiving Chemotherapy in the United States: A Budget Impact Analysis from the Payer Perspective. (Pubmed Central) - Apr 7, 2019
The effective annual plan per-patient drug costs for tbo-filgrastim and filgrastim-sndz were 11% and 15% lower than filgrastim, respectively. The present analysis estimated an annual U.S. health plan cost savings approaching $0.5 million following increases in market shares of approximately 5% for tbo-filgrastim and 2% for filgrastim-sndz.
- | Zarzio (filgrastim biosimilar) / Novartis
Clinical, P3 data, Journal: Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase 3, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. (Pubmed Central) - Apr 5, 2019
This phase III randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel + doxorubicin + cyclophosphamide) compares reference filgrastim, Neupogen® (Amgen), with two groups receiving alternating treatment with reference and biosimilar every other cycle...No neutralising antibodies were detected. There were no clinically meaningful results regarding efficacy, safety or immunogenicity when switching from reference to biosimilar filgrastim/EP2006, or vice versa.
- | Zarzio (filgrastim biosimilar) / Novartis
Clinical, Journal: Clinical Outcomes of Treatment with Filgrastim Versus a Filgrastim Biosimilar and Febrile Neutropenia-Associated Costs Among Patients with Nonmyeloid Cancer Undergoing Chemotherapy. (Pubmed Central) - Dec 18, 2018
In this real-world study of patients with nonmyeloid cancers undergoing chemotherapy, the incidence of FN was statistically equivalent between individuals treated with filgrastim-sndz versus filgrastim-ref during their first chemotherapy cycle. FN-related health care resource utilization and medical costs among patients who developed FN were substantial.
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz
Enrollment change: Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Nov 21, 2018
P1/2, N=55, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
FN-related health care resource utilization and medical costs among patients who developed FN were substantial. N=21 --> 55
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Nov 13, 2018
P2, N=200, Recruiting, Sponsor: M.D. Anderson Cancer Center
N=21 --> 55 Trial completion date: Apr 2021 --> Apr 2020
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment change, Trial completion date: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Nov 6, 2018
P1/2, N=44, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Apr 2021 --> Apr 2020 N=22 --> 44 | Trial completion date: May 2021 --> May 2020
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Trial completion date, Trial primary completion date: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Sep 14, 2018
P1/2, N=22, Recruiting, Sponsor: M.D. Anderson Cancer Center
N=22 --> 44 | Trial completion date: May 2021 --> May 2020 Trial completion date: May 2022 --> May 2021 | Trial primary completion date: May 2021 --> May 2020
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, P3 data, Journal: Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials. (Pubmed Central) - Aug 10, 2018
Trial completion date: May 2022 --> May 2021 | Trial primary completion date: May 2021 --> May 2020 LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis
Retrospective data, Journal: Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. (Pubmed Central) - May 26, 2018
P3
LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim. The current analysis reports data pooled from two independent, multinational, prospective, randomized, controlled, double-blind phase III studies of similar design comparing the safety and efficacy of reference pegfilgrastim with LA-EP2006 in patients with breast cancer receiving myelotoxic (neo)adjuvant TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy and requiring granulocyte colony-stimulating factor...NCT01735175, NCT01516736.
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial primary completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 23, 2018
P2, N=200, Recruiting, Sponsor: M.D. Anderson Cancer Center
The current analysis reports data pooled from two independent, multinational, prospective, randomized, controlled, double-blind phase III studies of similar design comparing the safety and efficacy of reference pegfilgrastim with LA-EP2006 in patients with breast cancer receiving myelotoxic (neo)adjuvant TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy and requiring granulocyte colony-stimulating factor...NCT01735175, NCT01516736. Trial completion date: Apr 2019 --> Apr 2021 | Trial primary completion date: Apr 2019 --> Apr 2020
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Trial completion date: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 19, 2018
P1/2, N=22, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Apr 2019 --> Apr 2021 | Trial primary completion date: Apr 2019 --> Apr 2020 Trial completion date: May 2021 --> May 2022
- | Zarxio (filgrastim-sndz) / Sandoz
New trial: Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes (clinicaltrials.gov) - Dec 7, 2017
P=N/A, N=70, Completed, Sponsor: University Hospital, Brest
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment change: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Nov 27, 2017
P1/2, N=22, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: May 2021 --> May 2022 N=30 --> 22
- | Zarxio (filgrastim-sndz) / Sandoz
Trial initiation date, Trial primary completion date: ZAPA: Use of Zarzio (clinicaltrials.gov) - Nov 25, 2017
P=N/A, N=62, Completed, Sponsor: University Hospital, Brest
N=30 --> 22 Initiation date: Jun 2012 --> Nov 2016 | Trial primary completion date: Nov 2014 --> Dec 2016
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Journal: A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. (Pubmed Central) - Nov 3, 2017
Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes. This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred.
- | Zarxio (filgrastim-sndz) / Sandoz
New trial: ZAPA: Use of Zarzio (clinicaltrials.gov) - Oct 26, 2017
P=N/A, N=62, Completed, Sponsor: University Hospital, Brest
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarzio (filgrastim biosimilar) / Novartis
Clinical: Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 25, 2017
P1/2, N=21, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred. Recruiting --> Active, not recruiting | N=55 --> 21
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Jun 14, 2017
P2, N=180, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | N=55 --> 21 Trial primary completion date: Apr 2018 --> Apr 2019
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen
Journal: Efficacious and save use of biosimilar filgrastim for hematopoietic progenitor cell chemo-mobilization with vinorelbine in multiple myeloma patients. (Pubmed Central) - Mar 11, 2017
Accordingly, the efficacy of the biosimilar filgrastim Zarzio® combined with vinorelbine for chemo-mobilization of CD34+ hematopoietic progenitor cells (HPC) in patients with multiple myeloma has not been evaluated yet. Apheresis, 2016.
- | Ziextenzo (pegfilgrastim biosimilar) / Novartis, Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Journal: Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. (Pubmed Central) - Mar 9, 2017
Apheresis, 2016. LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - May 3, 2016
P2, N=180, Recruiting, Sponsor: M.D. Anderson Cancer Center
LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy. Trial primary completion date: Apr 2017 --> Apr 2018
- || Zarxio (filgrastim-sndz) / Sandoz
Enrollment change: SMART: Non-interventional, Long-term Safety Data Collection of Zarzio (clinicaltrials.gov) - Mar 18, 2016
P=N/A, N=245, Active, not recruiting, Sponsor: Sandoz
Trial primary completion date: Apr 2017 --> Apr 2018 N=200 --> 245
- Zarxio (filgrastim-sndz) / Sandoz
Enrollment change, Trial termination, Trial primary completion date: Immunogenicity, Safety, and Efficacy of Zarzio (clinicaltrials.gov) - Nov 9, 2015
P4, N=6, Terminated, Sponsor: Sandoz
N=200 --> 245 N=40 --> 6 | Recruiting --> Terminated | Trial primary completion date: Dec 2015 --> Mar 2014; Additional pharmacovigilance activity was considered as fulfilled by the EMA.
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment open: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Sep 9, 2015
P1/2, N=30, Recruiting, Sponsor: M.D. Anderson Cancer Center
N=40 --> 6 | Recruiting --> Terminated | Trial primary completion date: Dec 2015 --> Mar 2014; Additional pharmacovigilance activity was considered as fulfilled by the EMA. Active, not recruiting --> Recruiting
- Zarxio (filgrastim-sndz) / Sandoz
Trial primary completion date: Immunogenicity, Safety, and Efficacy of Zarzio (clinicaltrials.gov) - Aug 13, 2015
P4, N=40, Recruiting, Sponsor: Sandoz
Active, not recruiting --> Recruiting Trial primary completion date: May 2015 --> Dec 2015
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment closed: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Aug 11, 2015
P1/2, N=30, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: May 2015 --> Dec 2015 Recruiting --> Active, not recruiting
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Apr 14, 2015
P2, N=180, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting Trial primary completion date: Apr 2016 --> Apr 2017
- ||| Zarxio (filgrastim-sndz) / Sandoz
Trial completion, Trial primary completion date: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (clinicaltrials.gov) - Oct 10, 2014
P=N/A, N=1500, Completed, Sponsor: Sandoz
Trial primary completion date: Apr 2016 --> Apr 2017 Recruiting --> Completed | Trial primary completion date: Aug 2012 --> Aug 2013
- || Zarxio (filgrastim-sndz) / Sandoz
Enrollment closed, Trial primary completion date: SMART: Non-interventional, Long-term Safety Data Collection of Zarzio (clinicaltrials.gov) - Oct 4, 2014
P=N/A, N=200, Active, not recruiting, Sponsor: Sandoz
Recruiting --> Completed | Trial primary completion date: Aug 2012 --> Aug 2013 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Aug 2024
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date: Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Sep 8, 2014
P2, N=180, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Aug 2024 Trial primary completion date: Apr 2015 --> Apr 2016
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment open: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - May 18, 2014
P1/2, N=30, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: Apr 2015 --> Apr 2016 Not yet recruiting --> Recruiting
- Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Enrollment change: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 7, 2014
P1/2, N=30, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting N=58 --> 30