Clinical trial · Interventional
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pixantrone, cyclophosphamide, vincristine, rituximab, prednisone | Drug | — | UNRESOLVED |
| Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Pixantrone (BBR2778)
- interventionNames
- Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
- type
- ACTIVE_COMPARATOR
- label
- Comparator Arm
- description
- To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
- interventionNames
- Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Primary outcomes (1)
- measure
- Complete Response (CR) and Complete Response Unconfirmed (CRu)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30. PMID 22652183