Clinical trial · Interventional
Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
A Prospective Randomized Comparative Study of the Effect on Infections of Radiated Prophylactic White Cell Transfusions Versus Therapeutic Radiated White Cell Transfusions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Recruitment
Summary
Brief summary (as posted)
Patients with leukemia often have low white blood cell counts after chemotherapy, which puts them at greater risk for infection. The standard of care for preventing infections is to give these patients antibiotic, antifungal, and antiviral drugs during the time that white blood cell counts are low. However, many patients still develop infections during chemotherapy. Radiated white blood cell transfusions are a standard treatment once a patient develops a severe infection. The goal of this clinical research study is to learn if giving unirradiated white blood cell transfusions early in chemotherapy might delay or prevent infections in patients with leukemia. Researchers also want to learn more about the type and severity of any infections that do occur.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic White Cell Transfusion | Procedure | — | UNRESOLVED |
| Therapeutic White Cell Transfusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 (Prophylactic Arm)
- description
- Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion
- interventionNames
- Procedure: Prophylactic White Cell Transfusion
- type
- EXPERIMENTAL
- label
- Arm 2 (Therapeutic Arm)
- description
- Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion
- interventionNames
- Procedure: Therapeutic White Cell Transfusion
Primary outcomes (1)
- measure
- Number of Participants With Infection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult and pediatric (=/\> 2 years old) patients with a diagnosis of acute myelogenous leukemia (including undifferentiated and bi-phenotypic leukemia), or high-risk myelodysplastic syndrome, or chronic myelogenous leukemia in blast crisis who will receive first or second anti-leukemia therapeutic intent with chemotherapy, targeted therapy or hypomethylating agents 2. Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. Exclusion Criteria: 1. Patients with baseline (at start leukemia treatment) infection, defined as patients with a)fever and known positive cultures at the time of randomization; or b) chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or c) one positive galactomannan test \>/= 1 or two positive galactomannan text \>/= 0.5 to 1 2. Patients with Zubrod performance status \>/= 3
References
Publications (0)
Data not yet available