Recurrent Adult Diffuse Large Cell Lymphoma Clinical Trial
Official title:
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)
This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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 cluster of differentiation (CD)20+ 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 unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 4 years.
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