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

Primary Purpose

Lymphoproliferative Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
bortezomib
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoproliferative Disorder focused on measuring post-transplant lymphoproliferative disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Minnesota Medical Center - Fairview
  • Washington University School of Medicine - Oncology Division

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated Patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Remission Duration Among Patients Who Respond to Treatment
Time to Treatment Failure
Relapse-free Survival
Overall Survival

Full Information

First Posted
March 25, 2009
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00869323
Brief Title
Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
Official Title
Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Funding unavailable
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab. Secondary To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients. To characterize the quantitative and qualitative toxicities of this regimen. OUTLINE: Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22. Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest. Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoproliferative Disorder
Keywords
post-transplant lymphoproliferative disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated Patients
Arm Type
Experimental
Arm Description
This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).
Intervention Type
Biological
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
375 mg/m^2 intravenously on Days 1,8, 15 and 22
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22
Primary Outcome Measure Information:
Title
Number of Patients With Overall (Complete and Partial) Response Rates
Time Frame
Day 1 to 2 Years Post Treatment
Secondary Outcome Measure Information:
Title
Remission Duration Among Patients Who Respond to Treatment
Time Frame
Day 1 to 8 Months Post Treatment
Title
Time to Treatment Failure
Time Frame
Day 1 to Time of Disease Progression
Title
Relapse-free Survival
Time Frame
at 2 years
Title
Overall Survival
Time Frame
at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H. Blaes, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine - Oncology Division
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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