- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058239
Bortezomib Plus Rituximab for EBV+ PTLD
Bortezomib Plus Rituximab for EBV + Post Transplant Lymphoproliferative Disease (PTLD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Both rituximab and bortezomib will be given to participants intravenously. Each cycle of treatment will consist of 21 days. Rituximab will be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles. Bortezomib will be given on Days 1, 4, 8 and 11 of every cycle. Participants will receive a maximum of 4 cycles.
- The following study procedures will be performed during each cycle throughout the study: Medical history review; Physical exam; Performance Status; Questionnaire; Blood draws and; PET/CT scans (After cycles 2, 4 and 6 only).
- After Cycle 4, if the study doctor feels the participant has had a complete response to treatment, then they will continue onto the Post-Treatment Surveillance period, which will consist of regular clinic visits over two years.
- However, if the study doctor feels the participant has had a partial response to treatment and that they may benefit from continuing, they will receive an additional two cycles of bortezomib and be given daily tablets of the antiviral drug valganciclovir to help further target EBV.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have had a prior solid organ or allogeneic stem cell transplant.
- Patients may be newly-diagnosed or relapsed after prior therapy
- Patients must have histologically confirmed CD20+ B-cell PTLD diagnosed according to WHO criteria. PTLD may be characterized as early lesions, PTLD/polymorphic, PTLD/monomorphic, or PTLD/other, all of which are eligible for this trial. B-cell PTLD must be associated with EBV as demonstrated either by detection of EBV antigens in tumor samples, or by increased EBV quantitative viral load in serum.
- Patients must have measurable disease
- 18 years of age or older
- Estimated life expectancy of > 3 months
- ECOG Performance status of 0, 1, or 2
- Adequate organ and marrow function
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria:
- Patients receiving any other study agents. Patients already on prophylactic doses of ganciclovir or valganciclovir because of a prior history of CMV infection or because of risk factors for CMV infection are eligible for the study and may continue CMV prophylaxis.
- Patients with known brain metastases or central nervous system (CNS) involvement of their lymphoma.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, rituximab, ganciclovir or valgancyclovir.
- Patients with Grade 2 or greater neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women
- Individuals with a history of malignancy are ineligible except for those outlined in the protocol
- Known HIV positive individuals
- Active HBV infection may be included only if they are on appropriate anti-hepatitis B therapy and have an undetectable HBV viral load
- Patient has received other investigational drugs within 14 days before enrollment
- Prior bortezomib
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab plus Bortezomib
This is a single arm trial adding the new drug bortezomib to the standard drug rituximab
|
Given intravenously on days 1, 4, 8 and 11 of every cycle
Other Names:
given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: 4 months
|
Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. The complete list of criteria used to evaluate response is too long to be detailed in the allotted space here, but response is defined more generally as:
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response Rate
Time Frame: 4 Months
|
The number of participants with complete responses as assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. |
4 Months
|
Six-Month Progression Free Survival
Time Frame: six months
|
Percent of participants with progression free survival (alive without disease progression) six months after registration. Progression was evaluated using the International Working Group criteria for lymphoma response. > Progressive Disease (PD) or Relapsed Disease (RD):
|
six months
|
Overall Survival
Time Frame: 6 months, 1 year
|
The percent of participants surviving at 6 months and 1 year.
|
6 months, 1 year
|
Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load
Time Frame: baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4)
|
The Mean epstein barr virus (EBV) viral load at the given time points.
|
baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4)
|
Treatment Related Toxicities
Time Frame: 2 years
|
The toxicities experienced by participants that were deemed to be related to the study treatment.
Data is shown as the number of participants that experienced any grade toxicity that was deemed to be related to treatment.
Toxicities were assessed with the use of Common Toxicology Criteria for Adverse Events (CTCAE).
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Immune System Diseases
- Lymphatic Diseases
- Immunoproliferative Disorders
- DNA Virus Infections
- Tumor Virus Infections
- Herpesviridae Infections
- Epstein-Barr Virus Infections
- Lymphoproliferative Disorders
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Bortezomib
Other Study ID Numbers
- 09-346
- X05289 (Other Identifier: Millennium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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