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General Information

Treanda is a rationally designed purine analog and alkylator hybrid. It damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis). It also stops cancer cells from dividing to create new cancer cells.

Treanda is specifically indicated for: 1) the treatment of chronic lymphocytic leukemia where efficacy relative to first line therapies other than chlorambucil has not been established, and 2) indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Treanda is supplied as a powder in a 100 mg vial to be reconstituted with sterile water for intravenous administration.

The recommended initial dose of the drug for the treatment of non-Hodgkin's lymphoma is 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles. Treanda administration should be delayed in the event of a Grade 4 hematologic toxicity or clinically significant > Grade 2 non-hematologic toxicity.
Dose modifications for hematologic toxicity: reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle. If Grade 4 toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.
Dose modifications for non-hematologic toxicity: reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle. If Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

The recommended initial dose of the drug for the treatment of chronic lymphocytic leukemia is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Treanda administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant >Grade 2 non-hematologic toxicity.
Dose modifications for hematologic toxicity: reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on Days 1 and 2 of each cycle.
Dose modifications for non-hematologic toxicity: reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle.

Clinical Results

FDA Approval

FDA approval for Treanda for the treatment of chronic lymphocytic leukemia was based on the results of an open-label, randomized, controlled multicenter trial in 301 previously-untreated patients with Binet Stage B or C (Rai Stages I - IV) CLL requiring treatment. The subjects received either Treanda at 100 mg/m2, administered intravenously over a period of 30 minutes on Days 1 and 2 or chlorambucil at 0.8 mg/kg administered orally on Days 1 and 15 of each 28-day cycle. Efficacy endpoints were objective response rate and progression-free survival. The overall response rate was 59% in the Treanda arm compared to 26% in the chlorambucil arm (p<0.0001). The median progression free survival was 18 months in the Treanda arm versus 6 months in the chlorambucil arm (p<0.0001).

FDA approval for Treanda for the treatment of non-Hodgkin's lymphoma was based on the results of a single arm study of 100 subjects with indolent B-cell NHL that had progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. All subjects received Treanda intravenously at a dose of 120 mg/m2, on Days 1 and 2 of a 21-day treatment cycle. They were treated for up to 8 cycles. Overall response rate was seen in 74 of the subjects (64.3%). The median duration of response was 9.2 months.

Side Effects

Adverse events associated with the use of Treanda for chronic lymphocytic leukemia may include, but are not limited to, the following:

pyrexia
nausea
vomiting
asthenia
fatigue
malaise
weakness
dry mouth
somnolence
cough
constipation
headache
mucosal inflammation
stomatitis

Adverse events associated with the use of Treanda for the treatment of non-Hodgkin's lymphoma may include, but are not limited to, the following:

nausea
fatigue
vomiting
diarrhea
pyrexia
fatigue
febrile neutropenia
pneumonia
hypokalemia
dehydration.

Mechanism of Action

Treanda contains bendamustine hydrochloride, an alkylating drug. Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. However, the exact mechanism of action of bendamustine remains unknown.

Literature References

Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. Journal of Clinical Oncology 2008 Jan 10;26(2):204-10

Lissitchkov T, Arnaudov G, Peytchev D, Merkle Kh Phase-I/II study to evaluate dose limiting toxicity, maximum tolerated dose, and tolerability of bendamustine HCl in pre-treated patients with B-chronic lymphocytic leukaemia (Binet stages B and C) requiring therapy. Journal of Cancer Research and Clinical Oncology 2006 Feb;132(2):99-104

Bergmann MA, Goebeler ME, Herold M, Emmerich B, Wilhelm M, Ruelfs C, Boening L, Hallek MJ; German CLL Study Group Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase I/II study of the German CLL Study Group. Haematologica 2005 Oct;90(10):1357-64

Weidmann E, Kim SZ, Rost A, Schuppert H, Seipelt G, Hoelzer D, Mitrou PS Bendamustine is effective in relapsed or refractory aggressive non-Hodgkin's lymphoma. Annals of oncology : official journal of the European Society for Medical Oncology 2002 Aug;13(8):1285-9

Kath R, Blumenstengel K, Fricke HJ, Höffken K Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia. Journal of Cancer Research and Clinical Oncology 2001 Jan;127(1):48-54