Phase 3
N=108
A Study for Leukemia Patients With Life-Threatening Infections
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00968838 ↗Enrolled (actual)
108
Serious AEs
7.4%
Results posted
Nov 2013
Primary outcome: Primary: Number of Participants Alive at Day 30 — 31; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- White Blood Cell Transfusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Alive at Day 30 |
31; 39 | — |
Summary
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.
Eligibility Criteria
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
- None
Data sourced from ClinicalTrials.gov (NCT00968838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.