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

Phase 3

Terminated

• Conditions: Breast Cancer; Chronic Myeloproliferative Disorders; Gestational Trophoblastic Tumor; Leukemia; Testicular Germ Cell Tumor; Infection; Multiple Myeloma and Plasma Cell Neoplasm; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
• Interventions: Drug: moxifloxacin hydrochloride; Drug: Placebo

• Registration Number: NCT00324324
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Primary Completion: 2007-04
• Study Completion: 2012-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moxifloxacin hydrochloride	moxifloxacin hydrochloride	Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
Sugar pill	Placebo	Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	1 to 120 days post bone marrow transplant

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of graft-versus-host disease	1 to 120 days post bone marrow transplant
Incidence of bacteremia	1 to 120 days post bone marrow transplant
Infection-related mortality	1 to 120 days post bone marrow transplant
Overall mortality	1 to 120 days post bone marrow transplant

Trial Locations

Locations (1)

Knight Cancer Institute at Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States