Official Title: “Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation”

RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

Study Primary Completion Date: April 2007

OBJECTIVES:

Primary - Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride during the post-engraftment phase in patients who have undergone allogeneic stem cell transplantation. (Pilot study) - Compare the efficacy, in terms of reducing the incidence of clinically and microbiologically documented bacterial infections, in patients who have undergone allogeneic stem cell transplantation treated with prophylactic moxifloxacin hydrochloride vs placebo during the post-engraftment phase. (Phase III)

Secondary - Determine the incidence of clinically and microbiologically documented bacterial infections in these patients. (Pilot study) - Assess the impact of moxifloxacin hydrochloride on the incidence of bacteremia in these patients. (Phase III) - Compare the percentage of time on systemic antibiotics and days hospitalized in patients treated with these regimens. (Phase III) - Compare the incidence of veno-occlusive disease of the liver in patients treated with these regimens. (Phase III) - Compare the incidence and severity of graft-versus-host disease in patients treated with these regimens. (Phase III) - Compare the infection-related mortality and overall mortality of patients treated with these regimens.

OUTLINE: This is a pilot study followed by a randomized, double-blind, placebo-controlled, multicenter phase III study. Patients are stratified according to gender and race (white vs.

non-white). The first 20 patients are assigned to the pilot study.

Patients assigned to the pilot study receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from allogeneic stem cell transplantation (ASCT) and continuing until day 100 post-transplantation in the absence of disease progression or unacceptable toxicity. Subsequent patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation. - Arm II: Patients receive oral placebo once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at day 120 post-transplantation.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: moxifloxacin hydrochloride

Primary Measures

• Safety and tolerability

Secondary Measures

• Incidence of bacteremia
• Days hospitalized
• Incidence and severity of graft-versus-host disease
• Infection-related mortality
• Overall mortality

DISEASE CHARACTERISTICS:

• Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT)
• Must not be undergoing a nonmyeloablative ASCT
• Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol
• No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed)

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 100 days
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Negative pregnancy test
• No known hypersensitivity to fluoroquinolones
• No prolonged QTc interval on EKG (i.e., QTc > 440 milliseconds)
• No uncontrolled hypokalemia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics
• No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University Cancer Institute

Overall Clinical Trial Officials and Contacts

Joseph Bubalo, PharmD, BCPS, BCOP Principal Investigator Oregon Health and Science University Cancer Institute  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00324324

Study ID Number: CDR0000472877

ClinicalTrials.gov Identifier: NCT00324324

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database