A Phase I/II Trial of Bendamustine/Treanda®, Rituximab, Etoposide, and Carboplatin for Patients With Relapsed or Refractory Lymphoid Malignancies and Select Untreated Lymphomas (TREC)
I. To estimate the maximally tolerated dose of bendamustine (bendamustine hydrochloride)
that can be combined with rituximab, carboplatin, and etoposide chemotherapy in patients
with relapsed or refractory lymphoid malignancies.
II. To determine the safety and toxicity of the above regimen.
I. To gain a preliminary assessment of the efficacy of the above regimen.
II. To determine the ability to proceed to peripheral blood stem cell collection following
the above regimen (the impact of above regimen on stem cell reserve).
III. To investigate whether findings from laboratory, radiographic or pathologic studies
have any prognostic impact on the response to treatment.
OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by
a phase II study.
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1
and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day
1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or
After completion of study treatment patients are followed up every 3 months for 1 year and
then every 6 months for 4 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose of bendamustine hydrochloride that can be combined with rituximab, carboplatin, and etoposide chemotherapy in patients with relapsed or refractory lymphoid malignancies
Defined as dose at which approximately =< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.
Up to 3-5 weeks after the last course
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|