Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

Peter Moosmann12 enrolled

Overview

The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.

Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population. Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Non-Hodgkin

Interventions

BendamustineDRUG

starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w

BortezomibDRUG

weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic recurrent or refractory indolent NHL or B-CLL * Adequate organ and bone marrow function * Karnofsky greater than 50% Exclusion Criteria: * Candidates for autologous stem cell transplantation * Secondary high grade lymphoma * Concurrent severe medical condition

Outcomes

Primary Outcomes

Optimal Bendamustine Dosage for Further Studies

Time frame: Three weeks after treatment termination

Data from ClinicalTrials.gov

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