Trial · NCT04189952
Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
NCT04189952, Phase 2, Terminated, University of Miami; results first posted 2022-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma. Trials, record NCT04189952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04189952
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
- NCT number
- NCT04189952
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Marginal Zone Lymphoma
- Interventions
- Acalabrutinib, Rituximab, Ifosfamide, Carboplatin, Etoposide
- First posted
- 2019-12-06
- Last updated
- 2025-05-31
- Results first posted
- 2022-09-19
- Limitations and caveats
- To protect participant privacy and maintain confidentiality, results will not be reported.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Complete Response (CR) | 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. |
| Secondary | Number of Treatment-Emergent Adverse Events | 13 weeks | The 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. |
| Secondary | Percentage of Participants Achieving Partial Response (PR) | 9 weeks | The percentage of participants achieving partial response (PR) will be assessed using Response Evaluation Criteria in Lymphoma (RECIL 2017) criteria. |
| Secondary | Percentage of Participants Achieving Overall Response | 9 weeks | Overall 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. |
| Secondary | Percentage of Participants Achieving Mobilization Rate Greater Than or Equal to 2x10^6 CD34+ Cells/kg Body Weight | 9 weeks | Percentage 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. |
| Secondary | Event-Free Survival (EFS) | Up to 61 weeks | Duration 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. |
| Secondary | Progression-Free Survival (PFS) | Up to 61 weeks | Duration 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). |
| Secondary | Overall Survival (OS) | Up to 61 weeks | Duration 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Complete Response (CR) | 9 weeks (End of Cycle 3) | percentage of participants | NUMBER | |
| SECONDARY | Number of Treatment-Emergent Adverse Events | 13 weeks | Treatment-emergent adverse events | NUMBER | |
| SECONDARY | Percentage of Participants Achieving Partial Response (PR) | 9 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants Achieving Overall Response | 9 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants Achieving Mobilization Rate Greater Than or Equal to 2x10^6 CD34+ Cells/kg Body Weight | 9 weeks | percentage of participants | NUMBER | |
| SECONDARY | Event-Free Survival (EFS) | Up to 61 weeks | weeks | NUMBER | |
| SECONDARY | Progression-Free Survival (PFS) | Up to 61 weeks | weeks | NUMBER | |
| SECONDARY | Overall Survival (OS) | Up to 61 weeks | weeks | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Complete Response (CR) | Acalabrutinib + R-ICE | NA | percentage of participants | ||
| Number of Treatment-Emergent Adverse Events | Acalabrutinib + R-ICE | NA | Treatment-emergent adverse events | ||
| Percentage of Participants Achieving Partial Response (PR) | Acalabrutinib + R-ICE | NA | percentage of participants | ||
| Percentage of Participants Achieving Overall Response | Acalabrutinib + R-ICE | NA | percentage of participants | ||
| Percentage of Participants Achieving Mobilization Rate Greater Than or Equal to 2x10^6 CD34+ Cells/kg Body Weight | Acalabrutinib + R-ICE | NA | percentage of participants | ||
| Event-Free Survival (EFS) | Acalabrutinib + R-ICE | NA | weeks | ||
| Progression-Free Survival (PFS) | Acalabrutinib + R-ICE | NA | weeks | ||
| Overall Survival (OS) | Acalabrutinib + R-ICE | NA | weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Acalabrutinib + R-ICE | 2 | |
| Treatment Period | COMPLETED | Acalabrutinib + R-ICE | 2 | |
| Treatment Period | NOT COMPLETED | Acalabrutinib + R-ICE | 0 | |
| Follow-up Period | STARTED | Acalabrutinib + R-ICE | 2 | |
| Follow-up Period | COMPLETED | Acalabrutinib + R-ICE | 0 | |
| Follow-up Period | NOT COMPLETED | Acalabrutinib + R-ICE | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acalabrutinib + R-ICE | 1 | 2 |
| Total, other adverse events | Acalabrutinib + R-ICE | 0 | 0 |
| Total, serious adverse events | Acalabrutinib + R-ICE | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04189952
GET https://conductscience.org/api/trials/v1/NCT04189952/registered