Bortezomib Plus Rituximab for EBV+ PTLD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01058239|
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-transplant Lymphoproliferative Disease Solid Organ Transplant Stem Cell Transplant (Bone Marrow Transplant) Epstein Barr Virus Infections||Drug: bortezomib Drug: rituximab||Phase 2|
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bortezomib Plus Rituximab for EBV + Post Transplant Lymphoproliferative Disease (PTLD)|
|Actual Study Start Date :||November 2011|
|Primary Completion Date :||December 2016|
|Study Completion Date :||November 2017|
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 Name: VelcadeDrug: rituximab
given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles
- 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:
- Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
- Partial Response (PR): ≥ 50% decrease in the sum of the products of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
- 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.
- 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):
- Appearance of any new lesion > 1.5 cm in any axis during or at end of therapy. Increased Radiolabeled[18F]-2-fluoro-2-deoxy-D-glucose (FDG) uptake in a previously unaffected site will be considered PD/RD only after confirmation by other modalities.
- ≥ 50% increase from nadir in the sum of the products of the largest diameters (SPD) of any previously involved node, or in a single involved node, or in the sizes of other lesions.
- ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis.
- PET (positron emission tomography) positive prior to therapy: post-treatment PET should be positive unless lesion is too small to be detected with current PET sys
- Overall Survival [ Time Frame: 6 months, 1 year ]The percent of participants surviving at 6 months and 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058239
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jeremy Abramson, MD||Massachusetts General Hospital|