Trial · NCT01415752
Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT01415752, Phase 2, Active not recruiting, Eastern Cooperative Oncology Group; results first posted 2025-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma. Trials, record NCT01415752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01415752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
- NCT number
- NCT01415752
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 373 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Lymphoma, Mantle Cell Lymphoma
- Interventions
- rituximab, Bendamustine, bortezomib, lenalidomide
- First posted
- 2011-08-12
- Last updated
- 2026-06-03
- Results first posted
- 2025-04-08
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) for Induction Phase | Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. * Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems |
| Primary | Progression-free Survival (PFS) for Maintenance Phase (Step 2) | Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | PFS is defined as time from Step 2 registration to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. * Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems |
| Secondary | Objective Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: * ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses * No increase in the size of other nodes, liver or spleen. * Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. * No new sites of disease. * Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. * When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders. |
| Secondary | PET-documented Complete Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | Complete response is defined as disappearance of all detectable clinical evidence of disease. |
| Secondary | Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) | Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5 | OS is defined as the time from registration of Step 2 (maintenance) until death from any cause or last know alive. The Kaplan-Meier estimate of 5-year OS rate is reported. |
| Secondary | Objective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of Induction | Assessed at baseline and every 4 months for 2 years | Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: * ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses * No increase in the size of other nodes, liver or spleen. * Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. * No new sites of disease. * Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. * When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders. |
| Other | To Collect Paraffin Embedded Tissue for Creation of Tissue Microarray | Assessed at baseline | Collection of paraffin embedded tissue for creation of tissue microarray |
| Other | To Collect and Bank Serum and Blood Mononuclear Cells for Future Studies | Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance | Collecting and banking serum and blood mononuclear cells for future studies |
| Other | To Collect Formalin Fixed Paraffin Embedded (FFPE) Tissue to Analyze Potential Prognostic Factors | Assessed at baseline | Collection of formalin fixed paraffin embedded (FFPE) tissue for future analysis of potential prognostic factors |
| Other | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx Subscale) Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. The higher the score, the better the quality of life. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) for Induction Phase | Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | Eligible and treated patients at Step 1 (induction) | years | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) for Maintenance Phase (Step 2) | Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | Eligible and treated patients at Step 2 (maintenance) | years | MEDIAN |
| SECONDARY | Objective Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | Eligible and treated patients at Step 1 (induction) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PET-documented Complete Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | |||
| SECONDARY | Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) | Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5 | Eligible and treated patients for the maintenance phase (Step 2) | Proportion of participants | NUMBER |
| SECONDARY | Objective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of Induction | Assessed at baseline and every 4 months for 2 years | |||
| OTHER_PRE_SPECIFIED | To Collect Paraffin Embedded Tissue for Creation of Tissue Microarray | Assessed at baseline | |||
| OTHER_PRE_SPECIFIED | To Collect and Bank Serum and Blood Mononuclear Cells for Future Studies | Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance | |||
| OTHER_PRE_SPECIFIED | To Collect Formalin Fixed Paraffin Embedded (FFPE) Tissue to Analyze Potential Prognostic Factors | Assessed at baseline | |||
| OTHER_PRE_SPECIFIED | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx Subscale) Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) for Induction Phase | Induction: Bendamustine + Rituximab (RB; Arms A + C) | 5.5 | 95% Confidence Interval 4.5 to 6.6 | years | |
| Progression-free Survival (PFS) for Induction Phase | Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) | 6.4 | 95% Confidence Interval 4.8 to 7.7 | years | |
| Progression-free Survival (PFS) for Maintenance Phase (Step 2) | Maintenance: Rituximab (R; Arms E + F) | 5.9 | 95% Confidence Interval 5.0 to 8.2 | years | |
| Progression-free Survival (PFS) for Maintenance Phase (Step 2) | Maintenance: Lenalidomide + Rituximab (LR; Arms G + H) | 7.2 | 95% Confidence Interval 5.5 to 7.8 | years | |
| Objective Response for Induction Phase (Step 1) | Induction: Bendamustine + Rituximab (RB; Arms A + C) | Objective response | 158 | Participants | |
| Objective Response for Induction Phase (Step 1) | Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) | Objective response | 158 | Participants | |
| Objective Response for Induction Phase (Step 1) | Induction: Bendamustine + Rituximab (RB; Arms A + C) | No objective response | 21 | Participants | |
| Objective Response for Induction Phase (Step 1) | Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) | No objective response | 21 | Participants | |
| Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) | Induction: (A) Bendamustine + Rituximab Then Maintenance: (E) Rituximab | 0.866 | 95% Confidence Interval 0.758 to 0.928 | Proportion of participants | |
| Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) | Induction: (B) Bendamustine + Rituximab + Bortezomib Then Maintenance: (F) Rituximab | 0.828 | 95% Confidence Interval 0.711 to 0.901 | Proportion of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction (Step 1) | STARTED | Induction: Bendamustine + Rituximab Then Maintenance: Rituximab | 94 | |
| Induction (Step 1) | STARTED | Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab | 93 | |
| Induction (Step 1) | STARTED | Induction: Bendamustine + Rituximab Then Maintenance: Lenalidomide + Rituximab | 93 | |
| Induction (Step 1) | STARTED | Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Lenalidomide + Rituximab | 93 | |
| Induction (Step 1) | Included in the Analysis of Adverse Events | Induction: Bendamustine + Rituximab Then Maintenance: Rituximab | 93 | |
| Induction (Step 1) | Included in the Analysis of Adverse Events | Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab | 92 | |
| Induction (Step 1) | Included in the Analysis of Adverse Events | Induction: Bendamustine + Rituximab Then Maintenance: Lenalidomide + Rituximab | 93 | |
| Induction (Step 1) | Included in the Analysis of Adverse Events | Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Lenalidomide + Rituximab | 92 | |
| Induction (Step 1) | Included in the Efficacy Analysis | Induction: Bendamustine + Rituximab Then Maintenance: Rituximab | 90 | |
| Induction (Step 1) | Included in the Efficacy Analysis | Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab | 90 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events1,168
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 | Induction: Bendamustine + Rituximab (Arm A) | 61 | 93 | |
| other | Anemia | Blood and lymphatic system disorders | Induction: Bendamustine + Rituximab + Bortezomib (Arm B) | 54 | 92 | |
| other | Anemia | Blood and lymphatic system disorders | Induction: Bendamustine + Rituximab (Arm C) | 61 | 93 | |
| other | Anemia | Blood and lymphatic system disorders | Induction: Bendamustine + Rituximab + Bortezomib (Arm D) | 57 | 92 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Rituximab (Arm E) | 40 | 74 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Rituximab (Arm F) | 37 | 68 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Lenalidomide + Rituximab (Arm G) | 53 | 73 | |
| other | Anemia | Blood and lymphatic system disorders | Maintenance: Lenalidomide + Rituximab (Arm H) | 57 | 73 | |
| other | Edema limbs | General disorders | Induction: Bendamustine + Rituximab (Arm A) | 11 | 93 | |
| other | Edema limbs | General disorders | Induction: Bendamustine + Rituximab + Bortezomib (Arm B) | 14 | 92 |
1 to 10 of 1,168Source ClinicalTrials.gov
See all 1,168 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction: Bendamustine + Rituximab (Arm A) | 11 | 94 |
| Total, all-cause mortality | Induction: Bendamustine + Rituximab + Bortezomib (Arm B) | 16 | 93 |
| Total, all-cause mortality | Induction: Bendamustine + Rituximab (Arm C) | 11 | 93 |
| Total, all-cause mortality | Induction: Bendamustine + Rituximab + Bortezomib (Arm D) | 11 | 93 |
| Total, all-cause mortality | Maintenance: Rituximab (Arm E) | 22 | 75 |
| Total, all-cause mortality | Maintenance: Rituximab (Arm F) | 20 | 68 |
| Total, all-cause mortality | Maintenance: Lenalidomide + Rituximab (Arm G) | 26 | 76 |
| Total, all-cause mortality | Maintenance: Lenalidomide + Rituximab (Arm H) | 17 | 74 |
| Total, other adverse events | Induction: Bendamustine + Rituximab (Arm A) | 92 | 93 |
| Total, other adverse events | Induction: Bendamustine + Rituximab + Bortezomib (Arm B) | 88 | 92 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38820500 | 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.
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