Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
This study has been terminated.
(Low Recruitment)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01204788
First received: September 15, 2010
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Procedure: Prophylactic White Cell Transfusion Procedure: Therapeutic White Cell Transfusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Randomized Comparative Study of the Effect on Infections of Radiated Prophylactic White Cell Transfusions Versus Therapeutic Radiated White Cell Transfusions |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Patients with Infection [ Time Frame: Blood draw 2-3 times a week while hospitalized, weekly thereafter. Patient will remain on study 42 days after transfusion. ] [ Designated as safety issue: No ]Primary outcome is infection (yes/no) where patient without infection found by day 42 patient are counted as 'No' to infection.
| Enrollment: | 5 |
| Study Start Date: | September 2010 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1 (Prophylactic Arm)
Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion
|
Procedure: Prophylactic White Cell Transfusion
Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
|
|
Experimental: Arm 2 (Therapeutic Arm)
Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion
|
Procedure: Therapeutic White Cell Transfusion
Radiated white blood cell transfusions daily only with infection (or persistent fever)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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:
- 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
- Patients with Zubrod performance status >/= 3
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204788
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | 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: | NCT01204788 History of Changes |
| Other Study ID Numbers: | 2010-0468 |
| Study First Received: | September 15, 2010 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Acute myelogenous leukemia AML Undifferentiated and bi-phenotypic leukemia High-risk myelodysplastic syndrome Chronic myelogenous leukemia |
Infection Radiated Prophylactic White Cell Transfusions Therapeutic Radiated White Cell Transfusion prophylactic antibiotics |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013