TREANDA was studied in patients with CLL in a pivotal phase 3 randomized trial
Phase 3 trial design
- Chlorambucil was chosen as the comparator because it was approved for first-line use in CLL in all participating countries when the pivotal trial was planned in 20011
*ORR includes patients with a best response of complete response (CR), nodular partial response (nPR), and partial response (PR) (ORR=CR+nPR+PR).
- Duration of treatment depended on response. Patients with CR, nPR, or PR after 3 cycles could receive 2 consolidation cycles, but no more than 6 cycles. Patients with stable disease (SD) were administered a total of at least 3 cycles. Patients with progressive disease (PD) discontinued treatment
Patients in the pivotal trial had a variety of disease-related issues
Baseline characteristics in both treatment groups
Indications
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia
(CLL). Efficacy relative to first-line therapies other than chlorambucil has not
been established.
TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab
or a rituximab-containing regimen.
Important Safety Information
- Serious adverse reactions, including myelosuppression, infections, infusion reactions
and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies,
and extravasation, have been associated with TREANDA. Some reactions, such as myelosuppression,
infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol
and other medications known to cause SJS/TEN), have been fatal. Patients should
be monitored closely for these reactions and treated promptly if any occur
- Adverse reactions may require interventions such as decreasing the dose of TREANDA,
or withholding or delaying treatment
- TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine
or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA
- The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) were pyrexia, nausea, and vomiting. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) were anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or usmedinfo@cephalon.com
- Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27:4378-4384.
- Data on file. Cephalon, Inc.
