Lymphoma Clinical Trial
Official title:
Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Levofloxacin With That of Cefepime in the Treatment of Fever and Neutropenia - Phase IIIB
RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of
neutropenia in patients who are being treated for cancer. It is not yet known whether
levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of
neutropenia.
PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that
of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are
being treated for cancer.
OBJECTIVES: I. Compare the safety and efficacy of levofloxacin versus cefepime in cancer
patients with fever and neutropenia. II. Compare the percentage of patients whose fever
defervesces and who have no signs or symptoms of infection with and without therapeutic
modification. III. Compare the percentage of survival of patients treated with these 2
regimens with no therapeutic modifications. IV. Compare the overall survival of patients
treated with these 2 regimens regardless of therapeutic modifications. V. Compare the time
to resolution of fever in patients treated with these regimens. VI. Compare the
microbiologic response by pathogen and site of infection in patients treated with these
regimens. VII. Compare the percentage of patients whose fever defervesces only after
resolution of neutropenia (absolute neutrophil count at least 500/mm3) with no therapeutic
modification.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to type of malignancy (solid tumor, including lymphoma vs leukemia), prior
prophylactic antibiotics (yes vs no), and participating center. Patients are randomized to
one of two treatment arms. Arm I: Patients receive levofloxacin IV over 90 minutes once
daily for 14-28 days. Arm II: Patients receive cefepime IV over 30 minutes every 8 hours for
14-28 days. Patients may receive additional antifungal, antibacterial, or antiviral therapy
if condition has deteriorated, no response is seen in 72 hours, or and infection is
suspected or documented. Patients are followed at 1-3 and 7-12 days and then at 3-4 weeks.
PROJECTED ACCRUAL: Approximately 260-400 patients (130-200 per treatment arm) will be
accrued for this study.
;
Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
| Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
| Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
| Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
| Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
| Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |