Trial · NCT04665765
Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04665765, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2024-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Trials, record NCT04665765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04665765
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- NCT number
- NCT04665765
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Diffuse Large B-Cell Lymphoma Unclassifiable, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- Interventions
- Carboplatin, Etoposide, Ifosfamide, Polatuzumab Vedotin, Rituximab
- First posted
- 2020-12-14
- Last updated
- 2026-09-11
- Results first posted
- 2024-08-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy | After 2 cycles of salvage therapy (each cycle is 21 days) | Estimated by the proportion of response-evaluable patients achieving CR after 2 cycles of salvage therapy, along with the 95% exact binomial confidence interval. Polatuzumab vedotin (Pola) was added to rituximab, ifosfamide, carboplatin, and etoposide (PolaR-ICE) as salvage therapy. |
| Primary | Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Phase 2 Stage) | During the first 2 cycles of PolaR-ICE salvage therapy (each cycle is 21 days) | Unacceptable toxicity was defined as the events in Section 11.2 occurring during the first 2 cycles of treatment that was at least possibly related to study treatment. |
| Primary | Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Safety lead-in Stage) | During the first 2 cycles of PolaR-ICE salvage therapy (each cycle is 21 days) | Unacceptable toxicity was defined as the events in Section 11.2 occurring during the first 2 cycles of treatment that was at least possibly related to study treatment. |
| Secondary | Overall Response Rate (ORR) of the PolaR-ICE Salvage Therapy | From initial treatment to the end of salvage therapy (up to three cycles). | Estimated by the proportion of response-evaluable participants that achieve a best response of either CR or partial response (PR) at the end of PolaR-ICE therapy, along with the 95% exact binomial confidence interval. Polatuzumab vedotin (Pola) was added to rituximab, ifosfamide, carboplatin, and etoposide (PolaR-ICE) as salvage therapy. |
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 | Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy | After 2 cycles of salvage therapy (each cycle is 21 days) | Three subjects in Phase II were not evaluable for they did not finish two cycles of treatment. | percentage of participants | NUMBER |
| PRIMARY | Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Phase 2 Stage) | During the first 2 cycles of PolaR-ICE salvage therapy (each cycle is 21 days) | events | NUMBER | |
| PRIMARY | Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Safety lead-in Stage) | During the first 2 cycles of PolaR-ICE salvage therapy (each cycle is 21 days) | events | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) of the PolaR-ICE Salvage Therapy | From initial treatment to the end of salvage therapy (up to three cycles). | Three subjects were not evaluable for they did not finish two cycles of treatment. | percentage of ORR participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy | Safety Lead-In | 67 | 95% Confidence Interval 22 to 96 | percentage of participants | |
| Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy | Phase II | 59 | 95% Confidence Interval 41 to 76 | percentage of participants | |
| Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Phase 2 Stage) | Treatment (PolaR-ICE) | 0 | events | ||
| Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Safety lead-in Stage) | Treatment (PolaR-ICE) | 0 | events | ||
| Overall Response Rate (ORR) of the PolaR-ICE Salvage Therapy | Treatment (PolaR-ICE) | 83 | 95% Confidence Interval 75 to 97 | percentage of ORR participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Lead-In | 6 | |
| Overall Study | STARTED | Phase II | 35 | |
| Overall Study | COMPLETED | Safety Lead-In | 6 | |
| Overall Study | COMPLETED | Phase II | 35 | |
| Overall Study | NOT COMPLETED | Safety Lead-In | 0 | |
| Overall Study | NOT COMPLETED | Phase II | 0 |
Source ClinicalTrials.gov
Adverse events314
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 | Safety Lead-In | 6 | 6 | 22 |
| other | Anemia | Blood and lymphatic system disorders | Phase II | 27 | 35 | 86 |
| other | Leukocytosis | Blood and lymphatic system disorders | Safety Lead-In | 0 | 6 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Phase II | 1 | 35 | 1 |
| other | Cardiac arrest | Cardiac disorders | Safety Lead-In | 0 | 6 | 0 |
| other | Cardiac arrest | Cardiac disorders | Phase II | 1 | 35 | 1 |
| other | Palpitations | Cardiac disorders | Safety Lead-In | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Phase II | 1 | 35 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Safety Lead-In | 1 | 6 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Phase II | 5 | 35 | 6 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Lead-In | 1 | 6 |
| Total, all-cause mortality | Phase II | 9 | 35 |
| Total, other adverse events | Safety Lead-In | 6 | 6 |
| Total, other adverse events | Phase II | 35 | 35 |
| Total, serious adverse events | Safety Lead-In | 1 | 6 |
| Total, serious adverse events | Phase II | 8 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41845899 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Safety Lead-In vs Phase II: deaths from any cause | Trial comparisons |
| Safety Lead-In vs Phase II: serious adverse events | Trial comparisons |
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/NCT04665765
GET https://conductscience.org/api/trials/v1/NCT04665765/events?page=2