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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI BioPharma
• Treatments: Cyclophosphamide; Etoposide; Gemcitabine; Pixantrone; Prednisone; Rituximab; Vincristine; Vinorelbine

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 2 weeks before randomization

• Pregnant women or nursing mothers