Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders

NCT00869323 | Terminated Phase 2 Results DMC

• 3 other identifiers: 2008LS043MT2008-05R0806M37121
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.

Conditions

Lymphoproliferative Disorder

Keywords

post-transplant lymphoproliferative disorder

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Overall (Complete and Partial) Response Rates

  Day 1 to 2 Years Post Treatment

Secondary Outcomes (4)

• Remission Duration Among Patients Who Respond to Treatment

  Day 1 to 8 Months Post Treatment

• Time to Treatment Failure

  Day 1 to Time of Disease Progression

• Relapse-free Survival

  at 2 years

• Overall Survival

  at 2 years

Study Arms (1)

Treated Patients

EXPERIMENTAL

This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).

Biological: rituximab; Drug: bortezomib

Interventions

rituximab BIOLOGICAL

375 mg/m\^2 intravenously on Days 1,8, 15 and 22

Also known as: Rituxan

Treated Patients

bortezomib DRUG

1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22

Also known as: Velcade

Treated Patients

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder
• Has undergone prior solid organ transplant
• Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³
• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
• Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal
• Total bilirubin ≤ 2.0 mg/dL

You may not qualify if:

• Pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Peripheral neuropathy ≥ grade 2
• Known lymphomatous meningitis or central nervous system (CNS) involvement
• HIV infection
• Uncontrolled infection
• Myocardial infarction within the past 6 months or uncontrolled angina
• New York Heart Association class III-IV heart failure
• Severe uncontrolled ventricular arrhythmias
• Evidence of acute ischemia or active conduction system abnormalities by electrocardiogram (EKG)
• Concurrent serious medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
• Diagnosis or treatment for another malignancy within the past 3 years, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
• Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents used in this study
• Less than 14 days since prior investigational drugs
• Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and recovered from toxic effects prior to enrollment

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (2)

University of Minnesota Medical Center - Fairview

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine - Oncology Division

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

Rituximab; Bortezomib

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Anne Blaes
• Organization: Masonic Cancer Center, University of Minnesota

blaes004@umn.edu

612-626-8138

Study Officials

• Anne H. Blaes, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: March 25, 2009
• First Posted: March 26, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2016
• Last Updated: December 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-12

Locations

US (2)