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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.
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 | 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: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00750737 History of Changes |
Health Authority: | United States: Institutional Review Board |
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 |
Abelcet Anti-Bacterial Agents Amphotericin B Mycoses Hematologic Neoplasms Clotrimazole |
Hematologic Diseases Miconazole Antifungal Agents Tioconazole Posaconazole Liposomal amphotericin B |
Abelcet Trypanocidal Agents Anti-Infective Agents Communicable Diseases Amphotericin B Antiprotozoal Agents Hematologic Neoplasms Hematologic Diseases Infection Liposomal amphotericin B Pharmacologic Actions |
Anti-Bacterial Agents Mycoses Antiparasitic Agents Neoplasms Neoplasms by Site Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Amebicides Posaconazole |