Trial · NCT01058239
Bortezomib Plus Rituximab for EBV+ PTLD
NCT01058239, Phase 2, Completed, Massachusetts General Hospital; results first posted 2018-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib Plus Rituximab for EBV+ PTLD. Trials, record NCT01058239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01058239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib Plus Rituximab for EBV+ PTLD
- NCT number
- NCT01058239
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Post-transplant Lymphoproliferative Disease, Solid Organ Transplant, Stem Cell Transplant (Bone Marrow Transplant), Epstein Barr Virus Infections
- Interventions
- bortezomib, rituximab
- First posted
- 2010-01-28
- Last updated
- 2018-02-15
- Results first posted
- 2018-02-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 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. |
| Secondary | Complete Response Rate | 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. |
| Secondary | Six-Month Progression Free Survival | 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): 1. 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. 2. ≥ 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. 3. ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. 4. 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 |
| Secondary | Overall Survival | 6 months, 1 year | The percent of participants surviving at 6 months and 1 year. |
| Secondary | Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | 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. |
| Secondary | Treatment Related Toxicities | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Response Rate | 4 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Six-Month Progression Free Survival | six months | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | 6 months, 1 year | percentage of participants | NUMBER | |
| SECONDARY | Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4) | Not all participants completed four cycles of treatment. The number of participants analyzed in each row differs according to the number of participants available for analysis at each time point. | Log2[(viral copies/ milliliter blood)+1] | MEAN |
| SECONDARY | Treatment Related Toxicities | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Rituximab Plus Bortezomib | 3 | Participants | ||
| Complete Response Rate | Rituximab Plus Bortezomib | 3 | Participants | ||
| Six-Month Progression Free Survival | Rituximab Plus Bortezomib | 43 | 90% Confidence Interval 14 to 70 | percentage of participants | |
| Overall Survival | Rituximab Plus Bortezomib | 6 month | 86 | 90% Confidence Interval 45 to 97 | percentage of participants |
| Overall Survival | Rituximab Plus Bortezomib | 12 Month | 86 | 90% Confidence Interval 45 to 97 | percentage of participants |
| Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | Rituximab Plus Bortezomib | Baseline | 13.02 | Standard Deviation 3.39 | Log2[(viral copies/ milliliter blood)+1] |
| Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | Rituximab Plus Bortezomib | End of Cycle 1 (21 days) | 10.12 | Standard Deviation 3.18 | Log2[(viral copies/ milliliter blood)+1] |
| Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | Rituximab Plus Bortezomib | End of Cycle 2 (42 days) | 9.11 | Standard Deviation 6.19 | Log2[(viral copies/ milliliter blood)+1] |
| Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | Rituximab Plus Bortezomib | End of Cycle 3 (63 days) | 8.98 | Standard Deviation 2.29 | Log2[(viral copies/ milliliter blood)+1] |
| Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load | Rituximab Plus Bortezomib | End of Cycle 4 (84 days) | 7.85 | Standard Deviation 0.34 | Log2[(viral copies/ milliliter blood)+1] |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab Plus Bortezomib | 7 | |
| Overall Study | COMPLETED | Rituximab Plus Bortezomib | 7 | |
| Overall Study | NOT COMPLETED | Rituximab Plus Bortezomib | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | Rituximab Plus Bortezomib | 2 | 7 | 3 |
| other | Cardiac arrest | Cardiac disorders | Rituximab Plus Bortezomib | 1 | 7 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab Plus Bortezomib | 1 | 7 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Rituximab Plus Bortezomib | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | Rituximab Plus Bortezomib | 1 | 7 | 2 |
| other | Catheter related infection | Infections and infestations | Rituximab Plus Bortezomib | 1 | 7 | 1 |
| other | Lung infection | Infections and infestations | Rituximab Plus Bortezomib | 1 | 7 | 1 |
| other | Lymphocyte count decreased | Investigations | Rituximab Plus Bortezomib | 4 | 7 | 19 |
| other | Neutrophil count decreased | Investigations | Rituximab Plus Bortezomib | 7 | 7 | 38 |
| other | Platelet count decreased | Investigations | Rituximab Plus Bortezomib | 7 | 7 | 37 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab Plus Bortezomib | 1 | 7 |
| Total, other adverse events | Rituximab Plus Bortezomib | 7 | 7 |
| Total, serious adverse events | Rituximab Plus Bortezomib | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01058239
GET https://conductscience.org/api/trials/v1/NCT01058239/events?page=2