A Study for Leukemia Patients With Life-Threatening Infections
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Procedure: White Blood Cell Transfusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- 30-Day Survival Rate [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]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).
| Enrollment: | 178 |
| Study Start Date: | April 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Non-radiated White Blood Cell Transfusion |
Procedure: White Blood Cell Transfusion
4 Transfusions, each taking approximately 1 hour: Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions. Patients >50 years of age are randomized to receive either radiated or non radiated transfusions. |
|
Experimental: White Blood Cell Transfusion
Standard white blood cell transfusion (with radiation)
|
Procedure: White Blood Cell Transfusion
4 Transfusions, each taking approximately 1 hour: Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions. Patients >50 years of age are randomized to receive either radiated or non radiated transfusions. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of hematologic malignancy admitted to the Leukemia service.
- Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000.
- Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
- Sign a written informed consent form.
- Greater than 18 years of age.
Exclusion Criteria:
1) None
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Emil J Freireich, MD, BS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968838 History of Changes |
| Other Study ID Numbers: | 2007-0797 |
| Study First Received: | August 27, 2009 |
| Last Updated: | September 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
White Blood Cell Transfusion Radiated Cells Unradiated Cells Leukocyte Transfusions Life-threatening Infections |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013