BBR 2778 for Relapsed, Aggressive Non-Hodgkin’s Lymphoma (NHL)

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 2 weeks before randomization
Pregnant women or nursing mothers