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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Enzon Pharmaceuticals, Inc. |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00750737 |
Purpose
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 |
|---|---|---|
|
Invasive Fungal Infections Hematologic Malignancies |
Drug: Posaconazole Drug: Amphotericin B Liquid Complex (ABLC) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1: Posaconazole |
Drug: Posaconazole
200 mg three times daily by mouth up to 6 weeks (Days 1-42)
Other Names:
|
| Experimental: 2: ABLC |
Drug: Amphotericin B Liquid 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)
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Issam Raad, MD/Professor | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00750737 History of Changes |
| Other Study ID Numbers: | 2007-0020 |
| Study First Received: | September 10, 2008 |
| Last Updated: | September 28, 2011 |
| 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 |
|
Neoplasms Mycoses Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Amphotericin B Liposomal amphotericin B Posaconazole Amebicides |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents Trypanocidal Agents |