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

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bendamustine

Drug

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

Other names: Ribomustin, SDX-105

bortezomib

Drug

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

Other names: Velcade

Primary outcomes

Optimal Bendamustine Dosage for Further Studies

Time frame: Three weeks after treatment termination

Sponsors and collaborators

Lead sponsor

Peter Moosmann

Other

Collaborators

Kantonsspital Aarau

Registry information

Official study title

Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jan 25, 2007
Registry last updated: Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed