Trial · NCT01691898
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
NCT01691898, Phase 1, Phase 2, Completed, Genentech, Inc.; results first posted 2018-04-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL). Trials, record NCT01691898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01691898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
- NCT number
- NCT01691898
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 231 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- Interventions
- Obinutuzumab, Pinatuzumab Vedotin, Polatuzumab Vedotin, Rituximab
- First posted
- 2012-09-25
- Last updated
- 2020-02-21
- Other registries' IDs
- eudract:2011-004377-84
- Results first posted
- 2018-04-19
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years) | Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (\>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a \>/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders. |
| Primary | Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years) | Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a \>/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. |
| Primary | Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H | 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) | Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to \[\</=\] mediastinum), or 3 (uptake less than \[\<\] mediastinum but \</=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. |
| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin | Baseline, post-baseline (up to approximately 5.5 years) | Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. |
| Secondary | Number of Participants With ADA to Polatuzumab Vedotin | Baseline, post-baseline (up to approximately 5.5 years) | Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. |
| Secondary | Number of Participants With ADA to Obinutuzumab | Baseline, post-baseline (up to approximately 5.5 years) | Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. |
| Secondary | Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years) | Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. |
| Secondary | Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years) | Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments \>/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years) | Percentage of participants who died due to any cause was reported. |
| Secondary | Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years) | OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment. | percentage of participants | NUMBER |
| PRIMARY | Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response. | months | MEDIAN |
| PRIMARY | Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H | 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks) | Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin | Baseline, post-baseline (up to approximately 5.5 years) | Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points. | participants | NUMBER |
| SECONDARY | Number of Participants With ADA to Polatuzumab Vedotin | Baseline, post-baseline (up to approximately 5.5 years) | Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points. | participants | NUMBER |
| SECONDARY | Number of Participants With ADA to Obinutuzumab | Baseline, post-baseline (up to approximately 5.5 years) | Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points. | participants | NUMBER |
| SECONDARY | Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C) | Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years) | Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population. | months | MEDIAN |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group155
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 59.5 | 90% Confidence Interval 45.67 to 72.32 | percentage of participants | |
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 61.9 | 90% Confidence Interval 41.72 to 79.43 | percentage of participants | |
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 53.8 | 90% Confidence Interval 39.58 to 67.65 | percentage of participants | |
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 70.0 | 90% Confidence Interval 49.22 to 86.04 | percentage of participants | |
Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Cohort C (FL): RTX + Polatuzumab | 75.0 | 90% Confidence Interval 54.44 to 89.59 | percentage of participants | |
| Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 6.24 | Full Range 0.89 to 22.57 | months | |
| Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 6.47 | Full Range 0.03 to 23.52 | months | |
| Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 13.37 | Full Range 0.03 to 35.68 | months | |
| Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 9.36 | Full Range 0.03 to 19.35 | months | |
| Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) | Cohort C (FL): RTX + Polatuzumab | 12.85 | Full Range 0.03 to 22.11 | months |
1 to 10 of 155Source ClinicalTrials.gov
See all 155 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 63 | |
| Overall Study | STARTED | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 59 | |
| Overall Study | STARTED | Cohort C (FL): RTX + Polatuzumab | 20 | |
| Overall Study | STARTED | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 9 | |
| Overall Study | STARTED | Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab | 40 | |
| Overall Study | STARTED | Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab | 40 | |
| Overall Study | COMPLETED | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 16 | |
| Overall Study | COMPLETED | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 15 | |
| Overall Study | COMPLETED | Cohort C (FL): RTX + Polatuzumab | 11 | |
| Overall Study | COMPLETED | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,596
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 | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 9 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 10 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C (FL): RTX + Polatuzumab | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 2 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab | 4 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab | 4 | 40 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 0 | 63 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 1 | 59 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort C (FL): RTX + Polatuzumab | 1 | 20 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 0 | 9 |
1 to 10 of 1,596Source ClinicalTrials.gov
See all 1,596 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 35 | 63 |
| Total, all-cause mortality | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 33 | 59 |
| Total, all-cause mortality | Cohort C (FL): RTX + Polatuzumab | 6 | 20 |
| Total, all-cause mortality | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 4 | 9 |
| Total, all-cause mortality | Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab | 8 | 40 |
| Total, all-cause mortality | Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab | 32 | 40 |
| Total, other adverse events | Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab | 63 | 63 |
| Total, other adverse events | Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab | 58 | 59 |
| Total, other adverse events | Cohort C (FL): RTX + Polatuzumab | 20 | 20 |
| Total, other adverse events | Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab | 9 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01691898
GET https://conductscience.org/api/trials/v1/NCT01691898/registered?page=2