Leukemia Clinical Trial
Official title:
Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients With Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine
Verified date | November 2013 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The goal of this clinical research study is to compare the effectiveness of a white blood cell transfusion with radiated cells to a white blood cell transfusion with cells that have not been radiated. The safety of this procedure will also be studied.
Status | Completed |
Enrollment | 178 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Diagnosis of hematologic malignancy admitted to the Leukemia service. 2. Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000. 3. Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics. 4. Sign a written informed consent form. 5. Greater than 18 years of age. Exclusion Criteria: 1) None |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Alive at Day 30 | Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion). | 30 Days | No |
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