Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	OHSU-TPI-02027-L NCT00324324

Objectives

Primary

1. 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)
2. 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

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

Entry Criteria

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)

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®)

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

Expected Enrollment

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

Outcomes

Safety and tolerability

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

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.

Bubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 2007.

Trial Contact Information

Trial Lead Organizations

Knight Cancer Institute at Oregon Health and Science University

Joseph Bubalo, PharmD, BCPS, BCOP, Principal investigator		Ph: 503-494-8007; 800-494-1234 Email: bubaloj@ohsu.edu

Registry Information
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
Trial Start Date		2006-05-22
Trial Completion Date		2007-04-01
Registered in ClinicalTrials.gov		NCT00324324
Date Submitted to PDQ		2006-03-22
Information Last Verified		2008-01-02
NCI Grant/Contract Number		CA69533

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