An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma

NCT01902862 | Terminated Phase 2

• 3 other identifiers: CR01034226866138LYM20212005-003949-14
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how well a participant can stand a particular medicine or treatment; ability to be used) of bortezomib in combination with rituximab standard therapy (medicine or medical care given to a participant for a disease or condition) in participants with relapsed or refractory (not responding to treatment) follicular lymphoma (a cancer of the lymph nodes \[or tissues\] in follicle).

Conditions

Lymphoma, Follicular

Keywords

Lymphoma, follicular; Bortezomib; Rituximab

Outcome Measures

Primary Outcomes (1)

• Time to Progression or Relapse

  Time to disease progression is defined as the time from start of treatment to the time of first documentation of disease progression.

  Start of treatment (Day 1 of Cycle 1) up to Month 15

Secondary Outcomes (4)

• Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Rituximab

  Start of treatment (Day 1 of Cycle 1) up to Month 15

• Number of Participants With Remission Status

  Start of treatment (Day 1 of Cycle 1) up to Month 15

• Disease-Free Survival

  Start of treatment (Day 1 of Cycle 1) up to Month 15

• Overall Survival

  Start of treatment (Day 1 of Cycle 1) up to Month 15

Study Arms (1)

Bortezomib plus rituximab

EXPERIMENTAL

Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m\^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3. Rituximab will be administered as intravenous infusion as 375 mg per m\^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

Drug: Bortezomib; Drug: Rituximab

Interventions

Bortezomib DRUG

Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m\^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

Also known as: VELCADE

Bortezomib plus rituximab

Rituximab DRUG

Rituximab will be administered as intravenous infusion as 375 mg pert m\^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

Bortezomib plus rituximab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically confirmed relapsed or refractory follicular Stage III or IV, Grade 1 and 2, cluster of differentiation 20 plus (CD20+) lymphoma (WHO - World Health Organization) that requires therapy
• Participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
• Women must be either postmenopausal or sterilized; negative pregnancy test at Screening
• Participants with total bilirubin below 1.5-fold upper limit of normal (ULN) and creatinine below 2-fold ULN
• Participants with Karnofsky Status greater than or equal to 60 percent

You may not qualify if:

• Participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
• Participants with previous known allergic reaction to bortezomib, boron or mannitol
• Participants with life-expectancy of less than 3 months
• Participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
• Participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (CTCAE) grade greater than or equal to 2

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (3)

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Stuttgart, Germany

Location

Related Links

• Pilot study with bortezomib in combination with rituximab standard therapy in patients with relapsed or refractory follicular lymphoma and at least 2 previous therapies

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bortezomib; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen-Cilag G.m.b.H, Germany Clinical Trial

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: July 18, 2013
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

DE (3)