MDACC Study Summary 2010-0468 (Archived)

Study Summary
No. 2010-0468:.......Leukemia......Emil J Freireich......Leukemia

Study Summary Title



Study Summary Number:	2010-0468

Study Title:	A Prospective Randomized Comparative Study of the Effect on Infections of Unirradiated Prophylactic White Cell Transfusions Versus Therapeutic Unirradiated White Cell Transfusions

Physician

New Patient Referral



Name:	Emil J Freireich	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2723 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	White Blood Cell Transfusion	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:

Description/
Intervention:

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.

Study Objectives / Outcomes

Primary Objective:
To determine if standard of care prophylactic antibiotics plus prophylactic white cell transfusions decrease the rate of infection compared to prophylactic antibiotics alone.

Secondary Objectives:
To compare prophylactic and therapeutic use of white cell transfusions in regards to:
a) Median number of febrile days and use of IV antibiotics;
b) Infection related MICU-admissions;
c) Length of hospitalization;
d) Leukemia response; and
e) Overall survival.

Study Status Information



Study Activation / Registration Date:	09/15/2010

IRB Review and Approval Date:	09/15/2010

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT01204788
Study Information on Clinical Trials Registry (clinicaltrials.gov)