Clinical trials: pMN
Chemotherapy-induced Neutropenia
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
- Trial name
- NEUGR-002 (NCT00837265)
- Testing
- Balugrastim, Pegfilgrastim, Chemotherapy Regimen
- Volunteers
- 334 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.
- Conditions
- Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, Membranous Nephropathy
- Trial name
- RENEW (NCT05162066)
- Testing
- BCX9930
- Where
- 11 sites in France, Italy and 2 more
- Volunteers
- 2 people
- Sponsor
- BioCryst Pharmaceuticals
Melanoma
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma.
- Trial name
- NCT00769704
- Testing
- Talimogene laherparepvec, GM-CSF
- Where
- 83 sites in United States, Canada and 2 more
- Volunteers
- 437 people
- Sponsor
- BioVex Limited
Chronic Myelogenous Leukemia
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of participants with chronic myeloid leukemia - chronic phase (CML-CP) having previously been treated…
- Trial name
- NCT03106779
- Testing
- Asciminib, Bosutinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 233 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Chronic Myelogenous Leukemia
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
- Trial name
- NCT04948333
- Testing
- ABL001 40mg BID, ABL001 80mg QD, ABL001 200mg QD
- Where
- 48 sites in Argentina, Austria and 14 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Large B-cell Lymphoma
Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most…
- Trial name
- ZUMA-19 (NCT04314843)
- Testing
- Cyclophosphamide, Fludarabine, Lenzilumab
- Where
- 10 sites in United States
- Volunteers
- 6 people
- Sponsor
- Kite, A Gilead Company
Infertility
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
- Trial name
- GM-CSF (NCT00565747)
- Testing
- Test culture, Control culture
- Where
- 14 sites in Denmark, Sweden
- Volunteers
- 1,332 people
- Sponsor
- Origio A/S
Neutropenic Complications, Breast Neoplasms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Conditions
- Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia, Chemotherapeutic Toxicity
- Trial name
- PROTECT-1 (NCT01735175)
- Testing
- LA-EP2006, Neulasta®
- Where
- 41 sites in Brazil, India and 4 more
- Volunteers
- 316 people
- Sponsor
- Sandoz
White Blood Cells
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep.
- Trial name
- CORNWALL (NCT01379768)
- Testing
- Lotrafilcon A contact lens, Lotrafilcon B contact lens, Clear Care Cleaning and Disinfection Solution
- Where
- Canada
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- CIBA VISION
Multiple Myeloma
A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
- Trial name
- GENESIS (NCT03246529)
- Testing
- BL-8040 1.25 mg/kg + G-CSF
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 180 people
- Sponsor
- BioLineRx, Ltd.
Granulocyte/ Polymorphonuclear Cells
Evaluation of the Spectra Optia PMN Cell Collection Procedure
The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.
- Trial name
- PMNC (NCT01805180)
- Testing
- Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System), Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Mycoses
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor…
- Trial name
- NCT01232504
- Testing
- rhGM-CSF group, rhG-CSF+rhGM-CSF group, rhG-CSF group
- Where
- 5 sites in China
- Volunteers
- 206 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Arthritis, Rheumatoid
Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
This study is designed to explore the activity of granulocyte-macrophage colony stimulating factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential impact of inhibition of this axis by…
- Trial name
- NCT02799472
- Testing
- GSK3196165, MTX, Folic (or folinic) acid
- Where
- 16 sites in United States, Germany and 1 more
- Volunteers
- 39 people
- Sponsor
- GlaxoSmithKline
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Neuroblastoma Recurrent
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
An International, Single-Arm, Multicenter Phase 2 Trial.
- Trial name
- NCT04560166
- Testing
- Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- Where
- 3 sites in Hong Kong, South Korea
- Volunteers
- 2 people
- Sponsor
- Y-mAbs Therapeutics
Postmenopausal Symptoms
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause.
- Trial name
- NCT03640754
- Testing
- G-CSF
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- MenoGeniX, Inc.
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited