Phase 3
N=140
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00088530 ↗Enrolled (actual)
140
Serious AEs
48.2%
Results posted
Jun 2017
Primary outcome: Primary: Complete Response (CR) and Complete Response Unconfirmed (CRu) — 20.0; 5.7; 24.3; 7.1 percentage of randomized patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone (Drug); Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CTI BioPharma
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) and Complete Response Unconfirmed (CRu) |
20.0; 5.7; 24.3; 7.1 | — |
| SECONDARY Progression-Free Survival (PFS) |
5.3; 2.6 | — |
| SECONDARY Overall Survival |
10.2; 7.6 | — |
| SECONDARY Overall Response Rate (ORR) Lasting at Least 4 Months |
12; 6 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00088530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.