Trial Outcomes & Findings for Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma (NCT NCT04189952)
NCT ID: NCT04189952
Last Updated: 2025-05-31
Results Overview
The percentage of participants achieving complete response (CR) will be assessed using Response Evaluation Criteria in Lymphoma (RECIL 2017) criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
9 weeks (End of Cycle 3)
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Acalabrutinib + R-ICE
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Treatment Period
STARTED
|
2
|
|
Treatment Period
COMPLETED
|
2
|
|
Treatment Period
NOT COMPLETED
|
0
|
|
Follow-up Period
STARTED
|
2
|
|
Follow-up Period
COMPLETED
|
0
|
|
Follow-up Period
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Acalabrutinib + R-ICE
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Follow-up Period
Death
|
1
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Follow-up Period
Withdrawal by Subject
|
1
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Baseline Characteristics
Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
Baseline characteristics by cohort
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeks (End of Cycle 3)The percentage of participants achieving complete response (CR) will be assessed using Response Evaluation Criteria in Lymphoma (RECIL 2017) criteria.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Percentage of Participants Achieving Complete Response (CR)
|
NA percentage of participants
Results not reported due to participant confidentiality.
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SECONDARY outcome
Timeframe: 13 weeksThe safety profile and tolerability of acalabrutinib + R-ICE will be reported as the number of treatment-emergent adverse events (AEs) or abnormalities of laboratory tests; serious adverse events (SAEs); dose-limiting toxicities (DLTs), or AEs leading to discontinuation of study treatment, or death. Severity and relationship will be assessed by the treating physician using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Number of Treatment-Emergent Adverse Events
|
NA Treatment-emergent adverse events
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: 9 weeksThe percentage of participants achieving partial response (PR) will be assessed using Response Evaluation Criteria in Lymphoma (RECIL 2017) criteria.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Percentage of Participants Achieving Partial Response (PR)
|
NA percentage of participants
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: 9 weeksOverall response is defined as the percentage of participants who achieved complete response (CR) or partial response (PR) to acalabrutinib + R-ICE therapy. Response will be assessed using Response Evaluation Criteria in Lymphoma (RECIL 2017) criteria.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Percentage of Participants Achieving Overall Response
|
NA percentage of participants
Results not reported due to participant confidentiality.
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SECONDARY outcome
Timeframe: 9 weeksPercentage of study participants achieving a mobilization rate of greater than or equal to 2x10\^6 CD34+ cells/kg body weight. Descriptive statistics will be used to summarize the mobilization rates.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Percentage of Participants Achieving Mobilization Rate Greater Than or Equal to 2x10^6 CD34+ Cells/kg Body Weight
|
NA percentage of participants
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: Up to 61 weeksDuration of Event-Free Survival (EFS) in study participants. EFS is defined as the time from first dose to documented disease progression, death from any cause, or study dropout, whichever occurs first.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Event-Free Survival (EFS)
|
NA weeks
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: Up to 61 weeksDuration of Progression-Free Survival (PFS) in study participants. PFS is defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, or have discontinued the study will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day).
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Progression-Free Survival (PFS)
|
NA weeks
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: Up to 61 weeksDuration of Overall Survival (OS) in study participants. OS is defined as the time from first dose to death from any cause. Data for subjects who are still alive at the time of data cutoff date, lost to follow-up, have discontinued the study (or, if no post-baseline assessment, at the time of first dose plus 1 day) will be censored.
Outcome measures
| Measure |
Acalabrutinib + R-ICE
n=2 Participants
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Acalabrutinib: Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
Rituximab: Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
Ifosfamide: Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
Carboplatin: Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
Etoposide: Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
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|---|---|
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Overall Survival (OS)
|
NA weeks
Results not reported due to participant confidentiality.
|
Adverse Events
Acalabrutinib + R-ICE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place