Clinical trials: Leukopenia
Neutropenia
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.
- Trial name
- NCT02629289
- Testing
- HSP-130, US-approved Neulasta, EU-approved Neulasta
- Where
- Australia
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Pfizer
Neutropenia, Fever
MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter…
- Trial name
- NCT00082537
- Testing
- caspofungin acetate, Comparator: AmBisome
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Leukopenia
Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)
A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection
- Trial name
- NCT00811928
- Testing
- Posaconazole, Fluconazole
- Volunteers
- 252 people
- Sponsor
- Merck Sharp & Dohme LLC
Chemotherapy-Induced Neutropenia, Breast Cancer
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six…
- Trial name
- NCT00501332
- Testing
- Maxy-G34
- Where
- 15 sites in Poland, Romania and 2 more
- Volunteers
- 30 people
- Sponsor
- Maxygen Holdings Ltd.
Neutropenia
FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy
The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.
- Trial name
- NCT00125723
- Testing
- PI Discretion
- Volunteers
- 2,252 people
- Sponsor
- Amgen
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
Hematological Malignancies, Neutropenia
Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients
The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever .
- Conditions
- Hematological Malignancies, Neutropenia, Fever
- Trial name
- NCT01060462
- Testing
- Pts. w/ neutropenic fever associated w/ hematologic malignancy
- Volunteers
- 438 people
- Sponsor
- Janssen Korea, Ltd., Korea
Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
- Trial name
- AVOID (NCT02044276)
- Testing
- lipegfilgrastim, pegfilgrastim
- Where
- 60 sites in Germany, Italy and 1 more
- Volunteers
- 101 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Neutropenia (Low White Blood Cell Count)
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as…
- Trial name
- NCT02766647
- Testing
- Filgrastim Hospira (US), US-approved Neupogen®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Neutropenia
Study to Compare the Efficacy and Safety of F-627 and GRAN®
A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte…
- Trial name
- NCT04174599
- Testing
- F-627, GRAN®
- Where
- China
- Volunteers
- 242 people
- Sponsor
- EVIVE Biotechnology
Non-Hodgkin's Lymphoma
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
- Trial name
- NCT00115193
- Testing
- pegfilgrastim
- Volunteers
- 77 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia, Cancer, Breast
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
- Trial name
- NCT03246009
- Testing
- rHSA/GCSF
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Tianjin SinoBiotech Ltd.
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
AML, CML
Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral…
- Conditions
- AML, CML, MDS
- Trial name
- NCT00684008
- Testing
- CYT107 - Recombinant glycosylated human interleukin 7., rhIL-7 (CYT107)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Cytheris, Inc.
Lymphopenia
Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and/or Radiation Therapy
This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, immunotherapy, and/or radiation therapy who may benefit from its use, and who are…
- Trial name
- NCT06956547
- Testing
- nogapendekin-alfa inbakicept
- Where
- United States
- Sponsor
- ImmunityBio, Inc.
Possible Fungal Infection
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against…
- Trial name
- IDEA (NCT00150345)
- Testing
- voriconazole (Vfend)
- Where
- 28 sites in Germany
- Volunteers
- 147 people
- Sponsor
- Pfizer
Healthy Volunteers
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants.
- Trial name
- NCT05194579
- Testing
- PF-06881894 by on-body injector, PF-06881894 by prefilled syringe
- Where
- 4 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Neutropenia
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
- Trial name
- NCT03252431
- Testing
- F-627, Neulasta
- Where
- United States
- Volunteers
- 393 people
- Sponsor
- EVIVE Biotechnology
MBL-Deficient, Neutropenia
Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.
- Trial name
- NCT00138736
- Testing
- Mannan Binding Lectin (MBL), Mannan Binding Lectin
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Prothya Biosolutions
Breast Cancer
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.
- Trial name
- NCT03404752
- Testing
- Peg-Filgrastim
- Where
- Argentina
- Volunteers
- 120 people
- Sponsor
- Gema Biotech S.A.