Clinical trials: Neutropenia
Mycoses, Candidiasis
A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants…
- Conditions
- Mycoses, Candidiasis, Aspergillosis, Cryptococcosis
- Trial name
- NCT00784368
- Testing
- ITCZ Oral Solution, ITCZ-IV
- Where
- Japan
- Volunteers
- 55 people
- Sponsor
- Janssen Pharmaceutical K.K.
Herpes Simplex
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of…
- Trial name
- NCT00855309
- Testing
- acyclovir sodium
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Wake Forest University Health Sciences
Advanced Metastatic (Stage IV) Colorectal Cancer
A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer
The present trial is designed to determine whether pre-treatment with PledOx lowers the frequency and severity of side effects from FOLFOX6 administration in patients with metastatic colorectal cancer.
- Trial name
- PLIANT (NCT01619423)
- Testing
- PledOx (2 µmol/kg), PledOx (5 µmol/kg), PledOx (10 µmol/kg)
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 186 people
- Sponsor
- Egetis Therapeutics AB (publ)
Diamond-Blackfan Anemia, Kostmann's Neutropenia
Stem Cell Transplant for Bone Marrow Failure Syndromes
The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for…
- Conditions
- Diamond-Blackfan Anemia, Kostmann's Neutropenia, Shwachman-Diamond Syndrome
- Trial name
- NCT00176878
- Testing
- Stem cell transplant, Fludarabine monophosphate, Total lymphoid irradiation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Myelodysplastic Syndrome (MDS) With Refractory Anemia (RA), Severe Aplastic Anemia (SAA)
Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic Syndrome
This study will evaluate the safety and effectiveness of treating patients with severe aplastic anemia (SAA) or myelodysplastic syndrome (MDS) with both peripheral blood stem cells from a family member and umbilical cord blood…
- Trial name
- NCT00604201
- Testing
- Umbilical Cord Blood
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease, Thalassemia
Stem Cell Transplant for Hemoglobinopathy
This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies.
- Conditions
- Sickle Cell Disease, Thalassemia, Severe Congenital Neutropenia, Diamond-Blackfan Anemia
- Trial name
- NCT00176852
- Testing
- Busulfan, Fludarabine, ATG, TLI, Busulfan, Cyclophosphamide, ATG, GCSF, Campath, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
Aplastic Anemia, Neutropenia
A Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic Anemia
Background: Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in low blood cell counts, which require frequent transfusions.
- Conditions
- Aplastic Anemia, Neutropenia, Pancytopenia, Severe Aplastic Anemia
- Trial name
- NCT01187017
- Testing
- Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Neutropenia
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
- Trial name
- NCT01724866
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 148 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Febrile Neutropenia
Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic patients. Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment…
- Trial name
- NCT01401010
- Testing
- Doripenem
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Gary E. Stein, Pharm.D.
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of…
- Trial name
- ADVANCE (NCT02643420)
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 81 sites in United States, Canada and 1 more
- Volunteers
- 406 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Acute Leukemias of Ambiguous Lineage, Bacterial Infection
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant.
- Conditions
- Acute Leukemias of Ambiguous Lineage, Bacterial Infection, Diarrhea, Fungal Infection
- Trial name
- NCT01371656
- Testing
- levofloxacin
- Where
- 84 sites in United States, Canada
- Volunteers
- 624 people
- Sponsor
- Children's Oncology Group
Severe Chronic Neutropenia
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed with severe chronic neutropenia.
- Trial name
- NCT01859637
- Testing
- Filgrastim
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 6 people
- Sponsor
- Sandoz
Aplastic Anemia
Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
Severe aplastic anemia, characterized by pancytopenia and a hypocellular bone marrow, is effectively treated by immunosuppressive therapy, usually a combination of antithymocyte globulin (ATG) and cyclosporine (CsA).
- Trial name
- NCT00065260
- Testing
- Campath-1H, r-ATG, CsA
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Colorectal Cancer Metastatic, Myelosuppression-Adult
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in…
- Conditions
- Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
- Trial name
- PRESERVE1 (NCT04607668)
- Testing
- Trilaciclib
- Where
- 82 sites in United States, China and 6 more
- Volunteers
- 326 people
- Sponsor
- G1 Therapeutics, Inc.
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg).
- Trial name
- NCT04345900
- Testing
- Plinabulin, Pegfilgrastim
- Where
- 19 sites in United States, China and 2 more
- Volunteers
- 55 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
Chemotherapy-induced Febrile Neutropenia
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
- Trial name
- NCT02178475
- Where
- 74 sites in Austria, Belgium and 7 more
- Volunteers
- 943 people
- Sponsor
- Amgen
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.
Chemotherapy-induced Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
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.
- Trial name
- PROTECT2 (NCT01516736)
- Testing
- LA-EP2006, Neulasta®
- Where
- 53 sites in United States, Argentina and 6 more
- Volunteers
- 308 people
- Sponsor
- Sandoz
Neutropenia, Sickle Cell Disease
Decitabine for High-Risk Sickle Cell Disease
Background: In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do not behave normally. In parts of the body where there are low levels of oxygen or where oxygen is used more, the sickle hemoglobin…
- Trial name
- NCT01375608
- Testing
- Decitabine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)