Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

NCT00510887 | Terminated Phase 2 Results

• 2 other identifiers: Pro000084878785
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Conditions

Lymphoma, Follicular

Keywords

follicular lymphoma; Velcade; VR-FND

Outcome Measures

Primary Outcomes (1)

• Complete and Partial Response

  * Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma. * Partial Response requires the following: * greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses. * No increase in size of other nodes, liver, or spleen. * Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD). * Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported. * No new lesions.

  1 year

Secondary Outcomes (5)

• Duration of Response

  up to 4 years

• Percentage of Subjects Experiencing Progression Free Survival

  up to 2 years

• Percentage of Subjects Experiencing Overall Survival

  up to 2 years

• Number of Participants With a Grade 3-4 Hematologic Toxicity.

  up to 1 year

• Number of Participants With Neuropathy, Any Grade

  up to 1 year

Study Arms (1)

VR-FND

EXPERIMENTAL

Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum.

Drug: Bortezomib; Drug: Rituximab; Drug: Fludarabine; Drug: Mitoxantrone; Drug: Dexamethasone

Interventions

Bortezomib DRUG

Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle

Also known as: Velcade

VR-FND

Rituximab DRUG

Rituximab 375 mg/m2 IV on day 1

VR-FND

Fludarabine DRUG

Fludarabine 25 mg/m2 IV on days 1,2,3

VR-FND

Mitoxantrone DRUG

Mitoxantrone 10 mg/m2 IV on day 2

Also known as: Novantrone

VR-FND

Dexamethasone DRUG

Dexamethasone 20 mg orally on days 1,2,3,4,5

VR-FND

Eligibility Criteria

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

You may qualify if:

• Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
• No prior bortezomib therapy.
• Voluntary written informed consent.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
• Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
• years of age or older.
• aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin \< 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Platelet count of \< 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
• Absolute neutrophil count of \< 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
• Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
• ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
• Female subject is pregnant or lactating.
• Received other investigational drugs for this disease within 14 days of enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Known HIV+ status.
• Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.

Sponsors & Collaborators

• Duke University: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bortezomib; Rituximab; fludarabine; Mitoxantrone; Dexamethasone

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; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quinones; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. David Rizzieri
• Organization: Duke University Medical Center

rizzi003@mc.duke.edu

919-668-1000

Study Officials

• David A Rizzieri, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: September 1, 2013
• Last Updated: May 12, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-04

Locations

US (1)