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Home > "A" Clinical Trials Conditions > A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.  A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
For Condition: Hematologic Neoplasms,Sepsis,Infection,Hematopoietic Stem Cell Transplantation
Status: Terminated
Sponsor(s): Eli Lilly and Company ,
Synopsis: The purpose of this study is to determine how Xigris® will affect leukemia, lymphoma and myeloma patients who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). This study will: ·Evaluate the safety of Xigris® by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death. ·Evaluate whether Xigris® can reduce death in BMT patients who develop severe sepsis.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Participants must have cancer of the blood (Leukemia, Lymphoma or Myeloma). 2. Participants must have had treatment in prepartation for a bone marrow transplant within the past 60 days. 3.Participants must have proven or suspected infection. 4.Participants must be on a breathing maching or require medication to maintain their blood pressure. Exclusion Criteria: 1.Participants must not have increased bleeding risk due to medical conditions or medications. 2.Participants must not be pregnant or breastfeeding. 3.Participants must not have serious liver disease. 4.Participants must not have been involved in a study of an investigational drug used to treat any disease other than cancer within the past 30 days.
Total Enrollment:
Location and Contact Information:
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
Iowa City, Iowa,
United States
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
Winston Salem, North Carolina,
United States
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
Durham, North Carolina,
United States
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
Denver, Colorado,
United States
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
Manhassaet, New York,
United States
Additional Information:
Study ID Numbers: 6416;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067730
Other Hematopoietic Stem Cell Transplantation Studies:
1. Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
2. Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
3. A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis
4. Inflammation, Infection, and Future Cardiovascular Risk
5. Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Related Studies:
Other Hematopoietic Stem Cell Transplantation Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
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