A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

Eli Lilly and Company7 enrolled

Overview

The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).

The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sepsis Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Infection

Interventions

Drotrecogin Alfa (activated)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have Leukemia, Lymphoma or Myeloma. * Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days. * Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure. * Participants must be on a breathing machine or require medication to maintain their blood pressure. Exclusion Criteria: * Participants must not have increased bleeding risk due to medical conditions or medications.

Locations (5)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Denver, Colorado, United States

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Safety

Time frame: 10 months

Secondary Outcomes

Mortality

Time frame: 10 months

Bleeding incidence

Time frame: 10 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.