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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Enzon Pharmaceuticals, Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00750737 |
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.
Condition | Intervention | Phase |
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Invasive Fungal Infections Hematologic Malignancies |
Drug: Posaconazole Drug: Amphotericin B Liquid Complex (ABLC) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Posaconazole: Experimental |
Drug: Posaconazole
3 times day by mouth for up to 6 weeks (Days 1-42)
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2: ABLC: Experimental |
Drug: Amphotericin B Liquid Complex (ABLC)
ABLC once a week by vein over 4-6 hours, for up to 6 weeks (from Day 1 through Day 42)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Issam Raad, MD/Professor | 713-792-7943 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Issam Raad, MD/Professor | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Issam Raad, MD/Professor ) |
Study ID Numbers: | 2007-0020 |
Study First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00750737 |
Health Authority: | United States: Institutional Review Board |
Hematologic Malignancies Blood Cancer Lymphatic Cancer Amphotericin B Lipid Complex ABLC |
Noxafil Posaconazole Invasive fungal infections Hematopoietic Stem Cell Transplant Bone Marrow Transplant |
Abelcet Amphotericin B Mycoses Hematologic Neoplasms Clotrimazole |
Hematologic Diseases Miconazole Tioconazole Posaconazole Liposomal amphotericin B |
Trypanocidal Agents Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Infection Pharmacologic Actions Anti-Bacterial Agents |
Neoplasms Antiparasitic Agents Neoplasms by Site Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Amebicides |