A Study for Leukemia Patients With Life-Threatening Infections

NCT00968838 | Completed Phase 3 Results DMC

• 1 other identifier: 2007-0797
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia

Keywords

White Blood Cell Transfusion; Radiated Cells; Unradiated Cells; Leukocyte Transfusions; Life-threatening Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants Alive at Day 30

  Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).

  30 Days

Study Arms (2)

Non-radiated White Blood Cell Transfusion

EXPERIMENTAL

Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.

Procedure: White Blood Cell Transfusion

White Blood Cell Transfusion

EXPERIMENTAL

Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.

Procedure: White Blood Cell Transfusion

Interventions

White Blood Cell Transfusion PROCEDURE

4 Transfusions, each taking approximately 1 hour: Patients \<50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions. Patients \>50 years of age are randomized to receive either radiated or non radiated transfusions.

Non-radiated White Blood Cell Transfusion; White Blood Cell Transfusion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \) None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia

Interventions

Leukocyte Transfusion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Emil J. Freireich MD/Professor
• Organization: The University of Texas M D Anderson Cancer Center

eharriso@mdanderson.org

713-792-2660

Study Officials

• Emil J Freireich, MD, BS

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 31, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 26, 2013
• Results First Posted: November 26, 2013

Record last verified: 2013-11

Locations

US (1)