Trial · NCT02853370
Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
NCT02853370, Phase 2, Completed, International Extranodal Lymphoma Study Group (IELSG); results first posted 2023-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma. Trials, record NCT02853370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02853370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
- NCT number
- NCT02853370
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Conditions
- Marginal Zone B-cell Lymphoma
- Interventions
- Bendamustine and Rituximab
- First posted
- 2016-08-02
- Last updated
- 2023-02-01
- Results first posted
- 2023-02-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate (CRR) | At the end of treatment (After 24 weeks of treatment) | Percentage of patients with complete response. Complete response to be assessed by means of CT-scan, Immunophenotype in blood and bone marrow (PET-scan optional) Complete response (CR) requires the disappearance of all evidence of disease 1. Regression to normal size on CT of organomegaly (splenomegaly, hepatomegaly and lymphoadenopathies) 2. Normalization of the blood counts (Hb \>12 g/dl; platelets \>100.000/mm3; neutrophils \>1.500/mm3 and no evidence of circulating clonal B-cells) 3. No evidence or minor (\<5%) BM infiltration detected by immunohistochemistry |
| Secondary | Overall Response Rate (ORR) | At the end of treatment (After 24 weeks of treatment) | Percentage of patients with complete and partial response. Partial response (PR) requires regression of 50% or greater in the measurable disease manifestations and no new sites of disease. This should include: resolution or decrease in spleen size, improvement on cytopenias and resolution or decrease in lymphadenopathy if present. Bone Marrow should show a decrease in the level of lymphoid infiltration and improvement of the haemopoietic reserve |
| Secondary | 3-year Progression Free Survival (PFS) | 3 years after study entry | Percentage of patients free from disease progression after 3 years from study entry. Progression is defined as reappearance of cytopenia or lymphoma relapse/ progression with enlarged lymph node(s) or spleen if present, histologic transformation or death as a result of any cause. |
| Secondary | 3-years Duration of Response (DOR) | 3 years from study entry | Percentage of responding patients after 3 years from study entry. DOR is defined for all patients who achieved a response (CR and PR) |
| Secondary | 3-years Event Free Survival (EFS) | 3 years after study entry | Percentage of patients free from events after 3 years from study entry. Events are defined as any treatment failure including disease progression, or discontinuation of treatment for any cause (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death). |
| Secondary | 3-years Overall Survival Rate | 3 years after treatment start | Percentage of patients alive after 3 years from study entry |
| Secondary | 5 Years Progression Free Survival (PFS) - | Five years after study entry | Percentage of patients free from disease progression after 5 years from treatment start. Progression is defined as reappearance of cytopenia or lymphoma relapse/ progression with enlarged lymph node(s) or spleen if present, histologic transformation or death as a result of any cause. |
| Secondary | 5 Years Overall Survival (OS) | Five years after study entry | Percentage of patients alive after 5 years from study entry |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate (CRR) | At the end of treatment (After 24 weeks of treatment) | Percentage of patients | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | At the end of treatment (After 24 weeks of treatment) | Percentage of patients | NUMBER | |
| SECONDARY | 3-year Progression Free Survival (PFS) | 3 years after study entry | Percentage of patients | NUMBER | |
| SECONDARY | 3-years Duration of Response (DOR) | 3 years from study entry | Percentage of patients | NUMBER | |
| SECONDARY | 3-years Event Free Survival (EFS) | 3 years after study entry | Percentage of patients | NUMBER | |
| SECONDARY | 3-years Overall Survival Rate | 3 years after treatment start | Percentage of patients | NUMBER | |
| SECONDARY | 5 Years Progression Free Survival (PFS) - | Five years after study entry | Percentage of patients | NUMBER | |
| SECONDARY | 5 Years Overall Survival (OS) | Five years after study entry | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate (CRR) | Bendamustine and Rituximab | 73 | 95% Confidence Interval 60 to 84 | Percentage of patients | |
| Overall Response Rate (ORR) | Bendamustine and Rituximab | 91 | 95% Confidence Interval 80 to 97 | Percentage of patients | |
| 3-year Progression Free Survival (PFS) | Bendamustine and Rituximab | 90 | 99% Confidence Interval 77 to 96 | Percentage of patients | |
| 3-years Duration of Response (DOR) | Bendamustine and Rituximab | 93 | 95% Confidence Interval 81 to 98 | Percentage of patients | |
| 3-years Event Free Survival (EFS) | Bendamustine and Rituximab | 80 | 95% Confidence Interval 65 to 89 | Percentage of patients | |
| 3-years Overall Survival Rate | Bendamustine and Rituximab | 96 | 95% Confidence Interval 84 to 98 | Percentage of patients | |
| 5 Years Progression Free Survival (PFS) - | Bendamustine and Rituximab | 83 | 95% Confidence Interval 71 to 91 | Percentage of patients | |
| 5 Years Overall Survival (OS) | Bendamustine and Rituximab | 93 | 95% Confidence Interval 82 to 97 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bendamustine and Rituximab | 56 | |
| Overall Study | COMPLETED | Bendamustine and Rituximab | 45 | |
| Overall Study | NOT COMPLETED | Bendamustine and Rituximab | 11 |
Source ClinicalTrials.gov
Adverse events24
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 | Anaemia | Blood and lymphatic system disorders | Bendamustine and Rituximab | 24 | 56 | 42 |
| other | Leukopenia | Blood and lymphatic system disorders | Bendamustine and Rituximab | 28 | 56 | 82 |
| other | Neutropenia | Blood and lymphatic system disorders | Bendamustine and Rituximab | 31 | 56 | 98 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bendamustine and Rituximab | 26 | 56 | 51 |
| other | Investigations | Investigations | Bendamustine and Rituximab | 3 | 56 | 4 |
| other | Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Bendamustine and Rituximab | 4 | 56 | 10 |
| other | Nervous system disorders | Nervous system disorders | Bendamustine and Rituximab | 3 | 56 | 3 |
| other | General disorders and administration site conditions | General disorders | Bendamustine and Rituximab | 13 | 56 | 22 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Bendamustine and Rituximab | 23 | 56 | 37 |
| other | Skin disorder | Skin and subcutaneous tissue disorders | Bendamustine and Rituximab | 10 | 56 | 19 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bendamustine and Rituximab | 4 | 56 |
| Total, other adverse events | Bendamustine and Rituximab | 50 | 56 |
| Total, serious adverse events | Bendamustine and Rituximab | 14 | 56 |
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/NCT02853370
GET https://conductscience.org/api/trials/v1/NCT02853370/events?page=2