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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neuroblastoma, Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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)

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®)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

1 to 120 days post bone marrow transplant

Safety Issue:

Yes

Principal Investigator

Joseph Bubalo, PharmD, BCPS, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000472877

NCT ID:

NCT00324324

Start Date:

May 2006

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Infection
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • infection
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • atypical chronic myeloid leukemia, BCR-ABL negative
  • blastic phase chronic myelogenous leukemia
  • chronic eosinophilic leukemia
  • primary myelofibrosis
  • chronic myelomonocytic leukemia
  • chronic neutrophilic leukemia
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • disseminated neuroblastoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • nodal marginal zone B-cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent neuroblastoma
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • recurrent small lymphocytic lymphoma
  • recurrent malignant testicular germ cell tumor
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage II ovarian epithelial cancer
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III multiple myeloma
  • stage III ovarian epithelial cancer
  • stage III small lymphocytic lymphoma
  • stage III malignant testicular germ cell tumor
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV breast cancer
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV ovarian epithelial cancer
  • stage IV small lymphocytic lymphoma
  • Bacterial Infections
  • Breast Neoplasms
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neuroblastoma
  • Ovarian Neoplasms
  • Trophoblastic Neoplasms
  • Lymphoma, Large-Cell, Immunoblastic
  • Neoplasms, Germ Cell and Embryonal
  • Gestational Trophoblastic Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098