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

Lymphoma, Non-Hodgkin Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426855
• Other study ID #: ZOHT-01/07
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 24, 2007
• Last updated: April 2, 2015
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2015
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Bendamustine
starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
• Bortezomib
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peter Moosmann	Kantonsspital Aarau

References & Publications (1)

Moosmann P, Heizmann M, Kotrubczik N, Wernli M, Bargetzi M. Weekly treatment with a combination of bortezomib and bendamustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2010 Jan;51(1):149-52. doi: 10.3109/10428190903275602. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal Bendamustine Dosage for Further Studies		Three weeks after treatment termination	Yes