Trial Outcomes & Findings for 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 NCT04665765)

Last Updated: 2025-09-03

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

After 2 cycles of salvage therapy (each cycle is 21 days)

Results posted on

2025-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Lead-In SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Overall Study STARTED	6	35
Overall Study COMPLETED	6	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Lead-In n=6 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II n=35 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Total n=41 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	29 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	28 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	35 participants n=7 Participants	41 participants n=5 Participants
Histology at On-Study Diffuse large B cell lymphoma NOS/De Novo	4 Participants n=5 Participants	23 Participants n=7 Participants	27 Participants n=5 Participants
Histology at On-Study Transformed Lymphoma	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Histology at On-Study Primary mediastinal large B cell lymphoma	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
B Symptoms at On-Study B Symptoms	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
B Symptoms at On-Study Absence of B symptoms	5 Participants n=5 Participants	28 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 2 cycles of salvage therapy (each cycle is 21 days)

Population: Three subjects in Phase II were not evaluable for they did not finish two cycles of treatment.

Outcome measures

Outcome measures
Measure	Safety Lead-In n=6 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II n=32 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy	67 percentage of participants Interval 22.0 to 96.0	59 percentage of participants Interval 41.0 to 76.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Safety Lead-In n=35 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Phase 2 Stage)	0 events	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Safety Lead-In n=5 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Safety lead-in Stage)	0 events	—

SECONDARY outcome

Timeframe: From initial treatment to the end of salvage therapy (up to three cycles).

Population: Three subjects were not evaluable for they did not finish two cycles of treatment.

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.

Outcome measures

Outcome measures
Measure	Safety Lead-In n=38 Participants SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Overall Response Rate (ORR) of the PolaR-ICE Salvage Therapy	83 percentage of ORR participants Interval 75.0 to 97.0	—

Adverse Events

Safety Lead-In

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase II

Serious events: 8 serious events

Other events: 35 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Alex Herrera , MD

City of Hope Medical Center

Phone: 6263598111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Safety Lead-In n=6 participants at risk SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV	Phase II n=35 participants at risk SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Polatuzumab Vedotin: Given IV Rituximab: Given IV
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Gastrointestinal disorders Ileus	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Gastrointestinal disorders Nausea	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
General disorders Multi-organ failure	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Infections and infestations COVID-19	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Infections and infestations Anorectal infection	16.7% 1/6 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	0.00% 0/35 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Infections and infestations Nail infection	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Infections and infestations Skin infection	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Investigations Platelet count decreased	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Psychiatric disorders Anxiety	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 3 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Vascular disorders Hypotension	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Vascular disorders Thromboembolic event	0.00% 0/6 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.	2.9% 1/35 • Number of events 1 • Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.