NCT01932710

Brief Summary

Patients with leukemia often have low white blood cell counts after chemotherapy, which puts them at greater risk of 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 white blood cell transfusions that are not radiated 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

September 20, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

August 27, 2013

Last Update Submit

January 10, 2018

Conditions

Leukemia

Keywords

LeukemiaAcute myelogenous leukemiaAMLHigh-risk myelodysplastic leukemiaMDSInfection riskWhite Blood Cell transfusionProphylactic therapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Utilizing White Cell Transfusion as a Prophylactic Therapy

    Study considered feasible if within one year, 20 patients enrolled with sufficient donors to donate white blood cells, two transfusion per week for six weeks (on average a total of 12 white blood transfusions per patient) to participate in the prophylactic therapy.

    6 weeks

Secondary Outcomes (1)

  • Infection Rate

    6 weeks

Study Arms (1)

White Blood Cell Transfusion

EXPERIMENTAL

Patient receives white blood cells by vein from a volunteer donor. Each transfusion will take anywhere from 1 hour to several hours, depending on how treatment is tolerated. Patient receives a transfusion every 3-4 days (at least 2 a week) for up to 6 weeks.

Procedure: White Blood Cell Transfusion

Interventions

White Blood Cell TransfusionPROCEDURE

Patient receives white blood cells by vein from a volunteer donor. Each transfusion will take anywhere from 1 hour to several hours, depending on how treatment tolerated. Transfusion received every 3-4 days (at least 2 a week) for up to 6 weeks.

White Blood Cell Transfusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All acute myelogenous leukemia and high-risk myelodysplastic leukemia patients who are admitted to the leukemia service and those who are referred from other services (i.e. pediatrics, medical oncology, etc.) will be eligible for the study.
  • Patients will be undergoing initial therapy for their disease or undergoing first salvage treatment, i.e. patients who fail therapy, or respond and relapse after initial therapy.
  • Patients will be free of signs and symptoms of infection at the time of entering the study and, most importantly, will be encouraged to have sufficient donors to administer prophylactic white cell transfusion twice a week for six weeks in order to assess their effectiveness.

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 registration; 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

Leukocyte Transfusion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Courtney DiNardo, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

September 20, 2013

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)