Trial · NCT02257242
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
NCT02257242, Phase 1, Completed, Brown University; results first posted 2023-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma. Trials, record NCT02257242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02257242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
- NCT number
- NCT02257242
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Brown University
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Small-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone
- Interventions
- Rituximab, Bendamustine, Vincristine sulfate liposome injection
- First posted
- 2014-10-06
- Last updated
- 2023-02-09
- Results first posted
- 2023-02-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | Up to 6 cycles of treatment (approximately 6 months) | Determined as the median of the marginal posterior distribution using data from all available patients |
| Secondary | Number of Participants Who Completed Six Cycles of Study Treatment | Up to 6 cycles of treatment (approximately 6 months) | |
| Secondary | Response Rate | Up to 6 cycles of treatment (approximately 6 months) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Complete Response Rate | Up to 6 cycles of treatment (approximately 6 months) | The number of patients achieving complete response during treatment on study |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose | Up to 6 cycles of treatment (approximately 6 months) | mg/m^2 | NUMBER | |
| SECONDARY | Number of Participants Who Completed Six Cycles of Study Treatment | Up to 6 cycles of treatment (approximately 6 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response Rate | Up to 6 cycles of treatment (approximately 6 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Response Rate | Up to 6 cycles of treatment (approximately 6 months) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | Dose-escalation Cohort | 2.24 | mg/m^2 | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 0 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 1 | Participants | ||
| Number of Participants Who Completed Six Cycles of Study Treatment | Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 1 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 2 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 2 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.10 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 1 | |
| Overall Study | STARTED | Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 1 | |
| Overall Study | COMPLETED | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events423
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 | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 0 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 1 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 1 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 1 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.1 mg/m^2 | 1 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 0 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 0 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 0 | 1 | |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 0 | 1 | |
| other | Alanine aminotransferase increased | Investigations | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 0 | 1 |
1 to 10 of 423Source ClinicalTrials.gov
See all 423 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 | 0 | 2 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.1 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 | 0 | 1 |
| Total, other adverse events | Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 | 1 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35641232 | DERIVED |
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/NCT02257242
GET https://conductscience.org/api/trials/v1/NCT02257242/results?page=2