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

Peter Moosmann

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: Bortezomib; Drug: Bendamustine

Study type: Interventional

Funder types: Other

Identifiers

NCT00426855

ZOHT-01/07

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Bendamustine and Bortezomib

Experimental group

Description:

Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section

Treatment:

Drug: Bortezomib

Drug: Bendamustine