Clinical Trial: Phase 3 BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)


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Sponsored by:	Cell Therapeutics
Information provided by:	Cell Therapeutics

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.

Condition	Treatment or Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: BBR2778	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Pixantrone (BBR 2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

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

Arizona
Arizona Hematology/Oncology, Tucson, Arizona, 85704, United States; Recruiting

Florida
Baptist Cancer Institute, Jacksonville, Florida, 32207, United States; Recruiting

Florida Oncology Associates, Orange Park, Florida, 32073, United States; Recruiting

Oncology Hematology Group of South Florida, Miami, Florida, 33176, United States; Recruiting

Osceola Cancer Center, Kissimmee, Florida, 34741, United States; Recruiting

Montana
Great Falls Clinic, Great Falls, Montana, 59405, United States; Recruiting

New Mexico
New Mexico Oncology/Hematology, Albuquerque, New Mexico, 87109, United States; Recruiting

New York
SUNY Upstate Medical University, Syracuse, New York, 13210, United States; Recruiting

Tennessee
Baptist Regional Cancer Center, Knoxville, Tennessee, 37920, United States; Recruiting

Study ID Numbers: PIX301
Record last reviewed: August 2004
Record first received: July 28, 2004
ClinicalTrials.gov Identifier: NCT00088530
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10