Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia

NCT01204788 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2010-0468NCI-2012-01795
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Infection

  Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.

  Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.

Study Arms (2)

Arm 1 (Prophylactic Arm)

EXPERIMENTAL

Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion

Procedure: Prophylactic White Cell Transfusion

Arm 2 (Therapeutic Arm)

EXPERIMENTAL

Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion

Procedure: Therapeutic White Cell Transfusion

Interventions

Prophylactic White Cell Transfusion PROCEDURE

Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops

Arm 1 (Prophylactic Arm)

Therapeutic White Cell Transfusion PROCEDURE

Radiated white blood cell transfusions daily only with infection (or persistent fever)

Arm 2 (Therapeutic Arm)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Disorders of Sex Development; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Emil Freireich, MD, Professor, Department of Medical Education
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-745-2723

Study Officials

• Emil J Freireich, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05

Locations

US (1)