Trial · NCT04659044
Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
NCT04659044, Phase 2, Terminated, Academic and Community Cancer Research United; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma. Trials, record NCT04659044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04659044
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
- NCT number
- NCT04659044
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3a Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Grade 1 Follicular Lymphoma, Refractory Grade 2 Follicular Lymphoma, Refractory Grade 3a Follicular Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Small Lymphocytic Lymphoma
- Interventions
- Polatuzumab Vedotin, Rituximab, Rituximab and Hyaluronidase Human, Venetoclax
- First posted
- 2020-12-09
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing a Complete Response (CR) | 3 months | Objective status of CR measured by positron emission tomography (PET)-computed tomography (CT) scans according to Lugano 2014. |
| Secondary | Overall Response Rate (ORR) | 3 months | The ORR at the end of induction will be estimated by the total number of patients who achieve a complete response (CR) or partial response (PR) by PET-CT scans according to Lugano 2014 divided by the total number of evaluable patients. The ORR between ibrutinib-naive and ibrutinib-pretreated patients will be compared using Fisher's exact test. |
| Secondary | Best Response Rate to Maintenance Therapy | At the end of maintenance therapy | CR, PR, and stable disease (SD) rates for patients who continue to maintenance will be estimated by number of patients who continue on maintenance therapy and achieve CR, PR or SD, respectively, at the end of maintenance divided by the total number of evaluable patients who continue to maintenance. |
| Secondary | Progression Free Survival (PFS) | 10 months | The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS between ibrutinib-naive and ibrutinib-pretreated patients will be compared using log-rank test. |
| Secondary | Overall Survival (OS) | 15 months | The distribution of OS will be estimated using the method of Kaplan-Meier. The OS between ibrutinib-naive and ibrutinib-pretreated patients will be compared using log-rank test. |
| Secondary | Count of Patients Experiencing Grade 3+ Adverse Events (AEs) | 15 months | All AEs occurring on or after first study treatment will be summarized by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 grade. |
| Other | Minimal Residual Disease (MRD) Analysis | Up to the end of maintenance therapy | MRD status for both responders and non-responders at each time point will be reported descriptively, and explored for correlation with clinical factors and patient outcomes such as PFS and OS. |
| Other | T Cell and Cytokine Subset Analysis | Up to the end of maintenance therapy | Systemic immune profiles and T cell activation will be investigated using multi-parameter flow cytometry, and cytokine analysis in the peripheral blood of patients. |
| Other | High Risk Cytogenetic Alterations | Up to the end of maintenance therapy | Will be summarized using frequency and percentages. |
| Other | Risk Stratification Scores | Up to the end of maintenance therapy | Will be summarized using frequency and percentages. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Experiencing a Complete Response (CR) | 3 months | Only patients that had at least one post-baseline disease assessment were included in analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | 3 months | Only patients that had at least one post-baseline disease assessment were included in analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Response Rate to Maintenance Therapy | At the end of maintenance therapy | No patients were on study long enough to receive maintenance therapy. | ||
| SECONDARY | Progression Free Survival (PFS) | 10 months | Only patients that had at least one post-baseline disease assessment were included in analysis | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 15 months | Only patients that had at least one post-baseline disease assessment were included in analysis | months | MEDIAN |
| SECONDARY | Count of Patients Experiencing Grade 3+ Adverse Events (AEs) | 15 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Minimal Residual Disease (MRD) Analysis | Up to the end of maintenance therapy | |||
| OTHER_PRE_SPECIFIED | T Cell and Cytokine Subset Analysis | Up to the end of maintenance therapy | |||
| OTHER_PRE_SPECIFIED | High Risk Cytogenetic Alterations | Up to the end of maintenance therapy | |||
| OTHER_PRE_SPECIFIED | Risk Stratification Scores | Up to the end of maintenance therapy |
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 |
|---|---|---|---|---|---|
| Number of Patients Experiencing a Complete Response (CR) | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 | Participants | ||
| Overall Response Rate (ORR) | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 | Participants | ||
| Progression Free Survival (PFS) | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 5.5 | 95% Confidence Interval 1.1 to NA | months | |
| Overall Survival (OS) | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | NA | 95% Confidence Interval 1.1 to NA | months | |
| Count of Patients Experiencing Grade 3+ Adverse Events (AEs) | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 3 | |
| Induction | COMPLETED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 | |
| Induction | NOT COMPLETED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 3 | |
| Maintenance Therapy | STARTED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 | |
| Maintenance Therapy | COMPLETED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 | |
| Maintenance Therapy | NOT COMPLETED | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 1 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 2 | 3 | 5 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 8 |
| other | Blood lactate dehydrogenase increased | Investigations | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 2 | 3 | 2 |
| other | Cholesterol high | Investigations | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 2 | 3 | 2 |
| other | Fatigue | General disorders | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 | 1 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 1 | 3 |
| Total, other adverse events | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 3 | 3 |
| Total, serious adverse events | Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT04659044
GET https://conductscience.org/api/trials/v1/NCT04659044/events?page=2