Trial · NCT00295932
Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
NCT00295932, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma. Trials, record NCT00295932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00295932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- NCT number
- NCT00295932
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Leukemia, Lymphoma
- Interventions
- rituximab, bortezomib, cyclophosphamide, prednisone
- First posted
- 2006-02-24
- Last updated
- 2018-11-20
- Results first posted
- 2018-11-20
- Limitations and caveats
- Analysis available and entered in the results section for Phase I participants. Cannot submit results on Phase II because analysis was incomplete when PI left MSK.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | 2 years | Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants |
| Secondary | Progression-free Survival | 2 years | |
| Secondary | Duration of Response (Mean and Median) | 2 years | |
| Secondary | Event-free Survival | 2 years | |
| Secondary | Overall Survival | 2 years | |
| Secondary | Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 2 years | Toxicity assessed using NCI-CTC v. 3.0 |
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 | Maximum Tolerated Dose | 2 years | This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level. | mg/m^2 of Bortezomib | NUMBER |
| SECONDARY | Progression-free Survival | 2 years | Data were not collected | ||
| SECONDARY | Duration of Response (Mean and Median) | 2 years | Data were not collected | ||
| SECONDARY | Event-free Survival | 2 years | Data were not collected | ||
| SECONDARY | Overall Survival | 2 years | Data were not collected | ||
| SECONDARY | Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | Arm I | Weekly Bortezomib | 1.8 | mg/m^2 of Bortezomib | |
| Maximum Tolerated Dose | Arm I | Twice-Weekly Bortezomib | 1.5 | mg/m^2 of Bortezomib | |
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 4 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 6 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 3 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 4 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 2 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 18 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 3 | Participants | ||
| Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma | Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 4 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 4 | |
| Overall Study | STARTED | 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 6 | |
| Overall Study | STARTED | 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 3 | |
| Overall Study | STARTED | 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 4 | |
| Overall Study | STARTED | Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 2 | |
| Overall Study | STARTED | Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 18 | |
| Overall Study | STARTED | Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 3 | |
| Overall Study | STARTED | Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 4 | |
| Overall Study | STARTED | Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 10 | |
| Overall Study | STARTED | Weekly Bortezomib Dosing Schedule | 12 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events1,265
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 | Constipation | Gastrointestinal disorders | 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 2 | 4 | |
| other | Constipation | Gastrointestinal disorders | 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 3 | 6 | |
| other | Constipation | Gastrointestinal disorders | 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 2 | 4 | |
| other | Constipation | Gastrointestinal disorders | Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 1 | 2 | |
| other | Constipation | Gastrointestinal disorders | Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 12 | 18 | |
| other | Constipation | Gastrointestinal disorders | Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 1 | 3 | |
| other | Constipation | Gastrointestinal disorders | Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 1 | 4 | |
| other | Constipation | Gastrointestinal disorders | Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 2 | 10 | |
| other | Constipation | Gastrointestinal disorders | Weekly Bortezomib Dosing Schedule | 0 | 12 |
1 to 10 of 1,265Source ClinicalTrials.gov
See all 1,265 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 3 | 4 |
| Total, all-cause mortality | 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 6 | 6 |
| Total, all-cause mortality | 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 2 | 3 |
| Total, all-cause mortality | 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 3 | 4 |
| Total, all-cause mortality | Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 1 | 2 |
| Total, all-cause mortality | Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 13 | 18 |
| Total, all-cause mortality | Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 2 | 3 |
| Total, all-cause mortality | Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 3 | 4 |
| Total, all-cause mortality | Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 7 | 10 |
| Total, all-cause mortality | Weekly Bortezomib Dosing Schedule | 4 | 12 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21346146 | RESULT |
Source PubMed
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/NCT00295932
GET https://conductscience.org/api/trials/v1/NCT00295932/flow?page=2