Trial · NCT00433537
Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
NCT00433537, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma. Trials, record NCT00433537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
- NCT number
- NCT00433537
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma
- Interventions
- bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, dexamethasone, filgrastim, pegfilgrastim, Autologous stem cell transplantation (ASCT)
- First posted
- 2007-02-12
- Last updated
- 2014-10-30
- Results first posted
- 2014-10-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | Assessed after VcR-CVAD cycles 2, 4, and 6. | Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. |
| Secondary | 2-year Progression-free Survival (PFS) | Assessed every 6 months for 5 years, and then yearly thereafter. | PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. |
| Secondary | 3-year Overall Survival (OS) | Assessed every 6 months for 5 years, and then yearly thereafter. | OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate | Assessed after VcR-CVAD cycles 2, 4, and 6. | Eligible and treated patients | proportion | NUMBER |
| SECONDARY | 2-year Progression-free Survival (PFS) | Assessed every 6 months for 5 years, and then yearly thereafter. | Eligible and treated patients who received maintenance rituximab or ASCT | probability | NUMBER |
| SECONDARY | 3-year Overall Survival (OS) | Assessed every 6 months for 5 years, and then yearly thereafter. | Eligible and treated patients who received maintenance rituximab or ASCT | probability | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate | VcR-CVAD Induction | 0.68 | 95% Confidence Interval 0.57 to 0.79 | proportion | |
| 2-year Progression-free Survival (PFS) | VcR-CVAD Induction Followed by Maintenance Rituximab | 0.79 | 95% Confidence Interval 0.67 to 0.92 | probability | |
| 2-year Progression-free Survival (PFS) | VcR-CVAD Induction Followed by ASCT | 0.76 | 95% Confidence Interval 0.58 to 1 | probability | |
| 3-year Overall Survival (OS) | VcR-CVAD Induction Followed by Maintenance Rituximab | 0.91 | 95% Confidence Interval 0.83 to 1 | probability | |
| 3-year Overall Survival (OS) | VcR-CVAD Induction Followed by ASCT | 0.96 | 95% Confidence Interval 0.87 to 1 | probability |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Step 1 - VcR-CVAD Induction | STARTED | VcR-CVAD Induction Followed by Maintenance Rituximab | 45 | |
| Step 1 - VcR-CVAD Induction | STARTED | VcR-CVAD Induction Followed by ASCT | 22 | |
| Step 1 - VcR-CVAD Induction | STARTED | VcR-CVAD Induction Then Off Study | 10 | |
| Step 1 - VcR-CVAD Induction | Eligible and Treated | VcR-CVAD Induction Followed by Maintenance Rituximab | 44 | |
| Step 1 - VcR-CVAD Induction | Eligible and Treated | VcR-CVAD Induction Followed by ASCT | 22 | |
| Step 1 - VcR-CVAD Induction | Eligible and Treated | VcR-CVAD Induction Then Off Study | 9 | |
| Step 1 - VcR-CVAD Induction | COMPLETED | VcR-CVAD Induction Followed by Maintenance Rituximab | 44 | |
| Step 1 - VcR-CVAD Induction | COMPLETED | VcR-CVAD Induction Followed by ASCT | 22 | |
| Step 1 - VcR-CVAD Induction | COMPLETED | VcR-CVAD Induction Then Off Study | 1 | |
| Step 1 - VcR-CVAD Induction | NOT COMPLETED | VcR-CVAD Induction Followed by Maintenance Rituximab | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events192
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 | Anemia | Blood and lymphatic system disorders | Step 1 - VcR-CVAD Induction | 71 | 77 | |
| other | Anemia | Blood and lymphatic system disorders | Step 2 - Maintenance Rituximab | 26 | 45 | |
| other | Leukocytes decreased | Investigations | Step 1 - VcR-CVAD Induction | 39 | 77 | |
| other | Leukocytes decreased | Investigations | Step 2 - Maintenance Rituximab | 21 | 45 | |
| other | Lymphopenia | Investigations | Step 1 - VcR-CVAD Induction | 39 | 77 | |
| other | Lymphopenia | Investigations | Step 2 - Maintenance Rituximab | 27 | 45 | |
| other | Neutrophils decreased | Investigations | Step 1 - VcR-CVAD Induction | 34 | 77 | |
| other | Neutrophils decreased | Investigations | Step 2 - Maintenance Rituximab | 12 | 45 | |
| other | Platelets decreased | Investigations | Step 1 - VcR-CVAD Induction | 67 | 77 | |
| other | Platelets decreased | Investigations | Step 2 - Maintenance Rituximab | 19 | 45 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Step 1 - VcR-CVAD Induction | ||
| Total, all-cause mortality | Step 2 - Maintenance Rituximab | ||
| Total, other adverse events | Step 1 - VcR-CVAD Induction | 76 | 77 |
| Total, other adverse events | Step 2 - Maintenance Rituximab | 40 | 45 |
| Total, serious adverse events | Step 1 - VcR-CVAD Induction | 72 | 77 |
| Total, serious adverse events | Step 2 - Maintenance Rituximab | 16 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24458437 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Step 1 - VcR-CVAD Induction vs Step 2 - Maintenance Rituximab: 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/NCT00433537
GET https://conductscience.org/api/trials/v1/NCT00433537/flow?page=2