Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Active | 18 and over | Pharmaceutical / Industry | PIX301 NCT00088530 |
Summary
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).
The objectives of this study are to compare the efficacy, safety, and tolerability of BBR2778 to a selection of single agents.
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification.
- At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
- Relapse after 2 or more prior regimens of chemotherapy
- ECOG performance status of 0, 1, or 2
- Adequate hematologic, renal and hepatic function
- LVEF ≥50% determined by MUGA scan
Exclusion Criteria:
- Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
- Prior allogenic stem cell transplant
- Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
- Active CNS lymphoma or HIV-related lymphoma.
- Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 4 weeks before randomization
- Pregnant women or nursing mothers
Trial Lead Organizations/Sponsors
Cell Therapeutics, Incorporated
| Jennifer Robertson |  | Ph: 1-800-916-9280 |
| Email: clinicaltrials@ctiseattle.com | ||
Trial Sites
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| U.S.A. | |||
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| Arizona | |||
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| Tucson | |||
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| Arizona Cancer Center at UMC Orange Grove | |||
| Florida | |||
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| Jacksonville | |||
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| Baptist Cancer Institute - Jacksonville | |||
| Kissimmee | |||
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| Osceola Cancer Center - Kissimmee | |||
| Miami | |||
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| Oncology-Hematology Group of South Florida, PA - Miami | |||
| Orange Park | |||
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| Integrated Community Oncology Network - Orange Park | |||
| Montana | |||
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| Great Falls | |||
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| Great Falls Clinic - Main Facility | |||
| New Mexico | |||
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| Albuquerque | |||
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| New Mexico Cancer Center | |||
| New York | |||
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| Syracuse | |||
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| SUNY Upstate Medical University Hospital | |||
| Tennessee | |||
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| Knoxville | |||
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| Baptist Regional Cancer Center at Baptist Riverside | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00088530
Information obtained from ClinicalTrials.gov on 2004-10-14
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