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

NCT00426855 | Completed Phase 1 Results

• 1 other identifier: ZOHT-01/07
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Lymphoma, Non-Hodgkin, Low-Grade

Outcome Measures

Primary Outcomes (1)

• Optimal Bendamustine Dosage for Further Studies

  Three weeks after treatment termination

Study Arms (1)

Bendamustine and Bortezomib

EXPERIMENTAL

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

Drug: Bendamustine; Drug: Bortezomib

Interventions

Bendamustine DRUG

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

Also known as: Ribomustin, SDX-105

Bendamustine and Bortezomib

Bortezomib DRUG

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

Also known as: Velcade

Bendamustine and Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic recurrent or refractory indolent NHL or B-CLL
• Adequate organ and bone marrow function
• Karnofsky greater than 50%

You may not qualify if:

• Candidates for autologous stem cell transplantation
• Secondary high grade lymphoma
• Concurrent severe medical condition

Sponsors & Collaborators

• Peter Moosmann: lead
• Kantonsspital Aarau: collaborator

Related 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. No abstract available.

  PMID: 19860608 RESULT

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Bendamustine Hydrochloride; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Peter Moosmann
• Organization: Kantonsspital Aarau

peter.moosmann@ksa.ch

+41 62 838 60 51

Study Officials

• Peter R Moosmann, MD PhD

  Cantonal Hospital of Aarau, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 25, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 3, 2015
• Results First Posted: April 3, 2015

Record last verified: 2015-04