Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
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ClinicalTrials.gov Identifier: NCT00750737 |
Recruitment Status :
Completed
First Posted : September 11, 2008
Results First Posted : January 6, 2016
Last Update Posted : September 29, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
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Invasive Fungal Infections Hematologic Malignancies | Drug: Posaconazole Drug: ABLC | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Clinical Trial of Oral Posaconazole 3 Times/Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) for Prevention of Invasive Fungal Infections In Patients With Hematologic Malignancies & Hematopoietic Stem Cell Transplant |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Experimental: Posaconazole
Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
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Drug: Posaconazole
200 mg three times daily by mouth up to 6 weeks (Days 1-42)
Other Names:
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Experimental: Amphotericin B Lipid Complex (ABLC)
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)
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Drug: ABLC
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)
Other Names:
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- Incidence of Invasive Fungal Infection (IFI) [ Time Frame: Within 7 days of antifungal prophylaxis therapy ]Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).
- Efficacy Outcome Measured as Success or Failure [ Time Frame: Day 1 through Day 42 ]Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750737
United States, Texas | |
UT MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Issam Raad, MD/Professor | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00750737 |
Other Study ID Numbers: |
2007-0020 |
First Posted: | September 11, 2008 Key Record Dates |
Results First Posted: | January 6, 2016 |
Last Update Posted: | September 29, 2016 |
Last Verified: | January 2016 |
Hematologic Malignancies Blood Cancer Lymphatic Cancer Amphotericin B Lipid Complex Amphotericin B ABLC Fungizone Noxafil |
SCH56592 Posaconazole Invasive fungal infections IFI Hematopoietic Stem Cell Transplant HSCT Bone Marrow Transplant Allogeneic hematopoietic stem cell transplant |
Infections Mycoses Invasive Fungal Infections Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Bacterial Infections and Mycoses Amphotericin B Posaconazole Amebicides Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Anti-Bacterial Agents Antifungal Agents Trypanocidal Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |