Trial · NCT00634179
A Phase I/II Trial of VR-CHOP in Lymphoma Patients
NCT00634179, Phase 1, Phase 2, Completed, Emory University; results first posted 2016-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Trial of VR-CHOP in Lymphoma Patients. Trials, record NCT00634179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00634179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Trial of VR-CHOP in Lymphoma Patients
- NCT number
- NCT00634179
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Lymphoma, B-Cell, Follicular Lymphoma
- Interventions
- Bortezomib, Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
- First posted
- 2008-03-12
- Last updated
- 2016-10-27
- Results first posted
- 2016-03-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) | Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks | INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression. |
| Secondary | An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Following completion of therapy, up to 2 years | Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) | Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks | mg/m^2 | NUMBER | |
| SECONDARY | An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Following completion of therapy, up to 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) | MTD of Bortezomib With Vincristine Capped at 1.5 mg | 1.62 | 95% Confidence Interval 0.63 to 1.88 | mg/m^2 | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase I: Induction | Complete Response (CR) | 13 | participants | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase II: Maintenance | Complete Response (CR) | 19 | participants | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase I: Induction | Partial Response (PR) | 6 | participants | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase II: Maintenance | Partial Response (PR) | 10 | participants | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase I: Induction | Overall Response Rate (ORR) | 19 | participants | |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria | Phase II: Maintenance | Overall Response Rate (ORR) | 29 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I: Induction | STARTED | Treatment (VR-CHOP Regimen) | 19 | |
| Phase I: Induction | COMPLETED | Treatment (VR-CHOP Regimen) | 19 | |
| Phase I: Induction | NOT COMPLETED | Treatment (VR-CHOP Regimen) | 0 | |
| Phase II: Maintenance | STARTED | Treatment (VR-CHOP Regimen) | 30 | |
| Phase II: Maintenance | COMPLETED | Treatment (VR-CHOP Regimen) | 29 | |
| Phase II: Maintenance | NOT COMPLETED | Treatment (VR-CHOP Regimen) | 1 |
Source ClinicalTrials.gov
Adverse events66
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 | Neutropenia | Blood and lymphatic system disorders | Phase I: Induction | 13 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase II: Maintenance | 14 | 29 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase I: Induction | 4 | 19 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase II: Maintenance | 3 | 29 | |
| other | Nausea | General disorders | Phase I: Induction | 13 | 19 | |
| other | Nausea | General disorders | Phase II: Maintenance | 2 | 29 | |
| other | Neuropathy | Nervous system disorders | Phase I: Induction | 16 | 19 | |
| other | Neuropathy | Nervous system disorders | Phase II: Maintenance | 22 | 29 | |
| other | Fatigue | General disorders | Phase I: Induction | 11 | 19 | |
| other | Fatigue | General disorders | Phase II: Maintenance | 1 | 29 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Induction | ||
| Total, all-cause mortality | Phase II: Maintenance | ||
| Total, other adverse events | Phase I: Induction | 16 | 19 |
| Total, other adverse events | Phase II: Maintenance | 22 | 29 |
| Total, serious adverse events | Phase I: Induction | 3 | 19 |
| Total, serious adverse events | Phase II: Maintenance | 1 | 29 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase I: Induction vs Phase II: Maintenance: serious adverse events |
Source Trial comparisons
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/NCT00634179
GET https://conductscience.org/api/trials/v1/NCT00634179/events?page=2