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 2 weeks
before randomization

- Pregnant women or nursing mothers