NCT00750737

Brief Summary

The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 6, 2016

Completed
Last Updated

September 29, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

September 10, 2008

Results QC Date

December 1, 2015

Last Update Submit

August 22, 2016

Conditions

Invasive Fungal InfectionsHematologic Malignancies

Keywords

Hematologic MalignanciesBlood CancerLymphatic CancerAmphotericin B Lipid ComplexAmphotericin BABLCFungizoneNoxafilSCH56592PosaconazoleInvasive fungal infectionsIFIHematopoietic Stem Cell TransplantHSCTBone Marrow TransplantAllogeneic hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Incidence of Invasive Fungal Infection (IFI)

    Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).

    Within 7 days of antifungal prophylaxis therapy

Secondary Outcomes (1)

  • Efficacy Outcome Measured as Success or Failure

    Day 1 through Day 42

Study Arms (2)

Posaconazole

EXPERIMENTAL

Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)

Drug: Posaconazole

Amphotericin B Lipid Complex (ABLC)

EXPERIMENTAL

7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)

Drug: ABLC

Interventions

PosaconazoleDRUG

200 mg three times daily by mouth up to 6 weeks (Days 1-42)

Also known as: SCH56592, Noxafil
Posaconazole
ABLCDRUG

7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)

Also known as: Amphotericin B Liquid Complex, Fungizone
Amphotericin B Lipid Complex (ABLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects: 18 years of age or above.
  • Any allogeneic hematopoietic stem cell transplant (HSCT) patient who is at risk of invasive fungal infection (IFI) within 6 months of the transplant will be eligible for the study according to HSCT institutional anti-fungal prophylaxis guidelines.
  • Subjects must be willing to give written informed consent and able to adhere to dosing and study visit schedule.
  • Female subjects of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[hCG\]) at Baseline or within 96 hours before the start of study drug.
  • Female subjects of childbearing potential must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Acceptable methods of contraception include condoms with/without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD (intrauterine device), oral/injectable hormonal contraceptive, surgical sterilization (e.g. hysterectomy/tubal ligation).

You may not qualify if:

  • Subjects previously treated with antifungal therapy (voriconazole, fluconazole, or itraconazole) for proven or probable IFI within 30 days of enrollment.
  • Subjects who have taken the following drugs: terfenadine, cisapride, primazide, and ebastine; that are known to interact with azoles and that may lead to life-threatening side effects, within 24 hours before study drug administration. And astemizole within 7 days before study drug administration.
  • Subjects who have taken the following drugs: cimetidine, rifampin, carbamezapine, phenytoin, rifabutin, barbiturates, isoniazid, and vinca alkaloids (vincristine, vinblastine); that are known to lower the serum concentration/efficacy of azole antifungal agents, within 24 hours before study drug administration.
  • Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents or Amphotericin B.
  • Subjects on other nephrotoxic agents (e.g. foscarnet).
  • Patients who are unable to take pills.
  • Subjects with proven or probable invasive fungal infection.
  • Subjects with renal insufficiency (estimated creatine clearance less than 50mL/minute at Baseline or likely to require dialysis during the study).
  • Subjects having ECG with a prolonged QTc interval by manual reading: QTc greater than 500 msec. at Baseline.
  • Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate amniotransferase (AST), alanine amniotransferase (ALT) and / or a total bilirubin level greater than 3 times the upper limit of normal (ULN).
  • Women who are breast feeding, pregnant, or intend to become pregnant during the course of the study.
  • Prior enrollment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chaftari AM, Hachem RY, Ramos E, Kassis C, Campo M, Jiang Y, Prince RA, Wang W, Raad II. Comparison of posaconazole versus weekly amphotericin B lipid complex for the prevention of invasive fungal infections in hematopoietic stem-cell transplantation. Transplantation. 2012 Aug 15;94(3):302-8. doi: 10.1097/TP.0b013e3182577485.

    PMID: 22814329DERIVED

Related Links

MeSH Terms

Conditions

Invasive Fungal InfectionsHematologic Neoplasms

Interventions

posaconazoleAmphotericin B

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Issam Raad, MD / Chair, Infectious Diseases
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-7943

Study Officials

  • Issam Raad, MD/Professor

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 29, 2016

Results First Posted

January 6, 2016

Record last verified: 2016-01

Locations

US(1)