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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CTI BioPharma
- Enrollment
- 140
- Locations
- 99
- Primary Endpoint
- Complete Response (CR) and Complete Response Unconfirmed (CRu)
Study Overview
Brief 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).
Detailed Description
The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Arm
Pixantrone (BBR2778)
Intervention: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone (Drug)
Comparator Arm
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Intervention: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab (Drug)
Outcomes
Primary Outcomes
Complete Response (CR) and Complete Response Unconfirmed (CRu)
Time Frame: EOT; approximately 6 months
Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)
Secondary Outcomes
- Progression-Free Survival (PFS)(18 months after 6 cycles of treatment; approximately 24 months)
- Overall Survival(18 months after 6 cycles of treatment; approximately 24 months)
- Overall Response Rate (ORR) Lasting at Least 4 Months(approximately 24 months)