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OpenTrials
Completed

NCT Number: NCT00067730

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

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).

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Key information

Conditions

Sepsis Hematologic Diseases Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Infection Infections Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

Other names: LY203638, Xigris

Primary outcomes

  1. Safety

    Time frame: 10 months

Secondary outcomes

  1. Mortality

    Time frame: 10 months

  2. Bleeding incidence

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis

Important dates

Study start
2003
Study completion
2003
First posted
Aug 27, 2003
Registry last updated
Dec 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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