Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia

NCT01500083 | Completed Phase 3 Results

• 1 other identifier: 14293A
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of the current study is to evaluate additional safety data of bendamustine in up to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in several countries, which have been shown to be reasonably well tolerated. The study protocol includes safety monitoring (i.e., adverse events, concomitant medications, supportive care, clinical safety laboratory tests, and clinical disease status monitoring). It is an interventional, multicentre, prospective, open-label expanded access study, which in addition allows investigators in Canada, and their patients, access to bendamustine while it is pending Canadian marketing approval. Although the treatment options available for patients with iNHL or CLL do induce substantial responses, there is no curative treatment. One potential drug candidate for the treatment of CLL and iNHL is bendamustine. Bendamustine has been widely used in Germany for more than 30 years and is marketed in the United States for treatment of CLL and for treatment of iNHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. In October 2010, the European Medicines Agency formally approved bendamustine in a number of Member States of the European Union for the treatment of patients with iNHL, CLL, and multiple myeloma. The drug's safety profile in these patient populations has been extensively characterized and no unexpected safety concerns are anticipated.

Conditions

Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia

Keywords

iNHL; CLL

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Up to 266 days

Study Arms (2)

Patients with Chronic Lymphocytic Leukemia (CLL)

EXPERIMENTAL

Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles.

Drug: Bendamustine at a dose of 100 mg/m2

Patients with Indolent Non-Hodgkin's Lymphoma (iNHL)

EXPERIMENTAL

Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles.

Drug: Bendamustine at a dose of 120 mg/m2

Interventions

Bendamustine at a dose of 100 mg/m2 DRUG

Bendamustine will be administered intravenously over 30 minutes.

Also known as: Treanda®

Patients with Chronic Lymphocytic Leukemia (CLL)

Bendamustine at a dose of 120 mg/m2 DRUG

Bendamustine will be administered intravenous (i.v.) over 60 minutes.

Also known as: Treanda®

Patients with Indolent Non-Hodgkin's Lymphoma (iNHL)

Eligibility Criteria

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

You may qualify if:

• The patient has biopsy-confirmed diagnosis of indolent B-cell NHL documented as relapsed or refractory iNHL (following rituximab-based therapy).
• The patient has one of the following types of indolent B-cell lymphoma:
• follicular lymphoma grade 1, 2, or 3A
• marginal zone lymphoma
• lymphoplasmacytic lymphoma
• small lymphocytic lymphoma
• The patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma).
• The patient has previously confirmed (according to WHO criteria) untreated symptomatic chronic B-cell lymphocytic leukemia Binet Stage B or Binet Stage C or Rai stage II to IV in need of medical treatment.
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

You may not qualify if:

• The patient has participated in a clinical study \<30 days prior to the Screening Visit.
• The patient has one or more of the following conditions:
• active transformed lymphoma
• any history of central nervous system or leptomeningeal lymphoma
• an active malignancy other than the target cancer within the past 5 years
• human immunodeficiency virus
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Sponsors & Collaborators

• Lundbeck Canada Inc.: lead

Study Sites (16)

CA015

Calgary, Alberta, T2N 4N2, Canada

Location

CA014

Edmonton, Alberta, T6G 1Z2, Canada

Location

CA016

Kelowna, British Columbia, V1Y 5L3, Canada

Location

CA011

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CA013

Victoria, British Columbia, V8R 6V5, Canada

Location

CA012

Winnipeg, Manitoba, R3E 0V9, Canada

Location

CA004

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

CA009

Brampton, Ontario, L6R 3J7, Canada

Location

CA003

Hamilton, Ontario, L8V 5C2, Canada

Location

CA002

Ottawa, Ontario, K1H 8L6, Canada

Location

CA006

Toronto, Ontario, M5G 2M9, Canada

Location

CA005

Windsor, Ontario, N8W 2X3, Canada

Location

CA001

Montreal, Quebec, H2W 1S6, Canada

Location

CA010

Montreal, Quebec, H4J 1C5, Canada

Location

CA007

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

CA008

Québec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Lundbeck Canada Inc.
• Organization: Lundbeck Canada Inc.

LundbeckClinicalTrials@lundbeck.com

+45 36301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 26, 2011
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 14, 2017
• Results First Posted: October 16, 2014

Record last verified: 2017-06

Locations

CA (16)