Trial · NCT04337827
Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder
NCT04337827, Phase 2, Terminated, Deepa Jagadeesh; results first posted 2024-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder. Trials, record NCT04337827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04337827
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder
- NCT number
- NCT04337827
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Deepa Jagadeesh
- Conditions
- Post-transplant Lymphoproliferative Disorder
- Interventions
- Rituximab, Acalabrutinib, CT scans
- First posted
- 2020-04-08
- Last updated
- 2024-04-10
- Results first posted
- 2024-04-10
- Limitations and caveats
- Early termination leading to small numbers of subjects, unable to perform analysis of data.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 8 weeks after treatment | ORR will be estimated along with 90% Confidence Intervals (CIs), and compared against the null using exact binomial test. Logistic regression model will be used to identify factors associated with response status. |
| Secondary | Complete Response Rate (CRR) | at 6 months after treatment | CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria |
| Secondary | Complete Response Rate (CRR) | at 12 months after treatment | CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria |
| Secondary | Complete Response Rate (CRR) | at 24 months after treatment | CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria |
| Secondary | Partial Response Rate (PRR) | at 6 months after treatment | PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria. |
| Secondary | Partial Response Rate (PRR) | at 12 months after treatment | PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria. |
| Secondary | Partial Response Rate (PRR) | at 24 months after treatment | PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria. |
| Secondary | Duration of Response (DOR) | Up to 3 years after treatment | DOR is only measured in responders. DOR is defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first. Subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued study, or have initiated other non-protocol anti-tumor therapy (NPT) will be censored at the last tumor assessment when subjects are progression-free. |
| Secondary | Progression Free Survival (PFS) | at 6 months after treatment | PFS as 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, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day) Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint. |
| Secondary | Progression Free Survival (PFS) | at 12 months after treatment | PFS as 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, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day) Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 8 weeks after treatment | Sponsor terminated financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close enrollment and to cease long-term follow-up of subjects. Zero participants were followed past the end of treatment for several reasons, including removal of funding that prevented follow-up or participants reaching stable disease (per protocol, participant does not get followed). Therefore, no data was collected. | ||
| SECONDARY | Complete Response Rate (CRR) | at 6 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 6 months; therefore, no data was collected. | ||
| SECONDARY | Complete Response Rate (CRR) | at 12 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 12 months, therefore, no data was collected. | ||
| SECONDARY | Complete Response Rate (CRR) | at 24 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 24 months, therefore, no data was collected. | ||
| SECONDARY | Partial Response Rate (PRR) | at 6 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 6 months; therefore, no data was collected. | ||
| SECONDARY | Partial Response Rate (PRR) | at 12 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 12 months, therefore, no data was collected. | ||
| SECONDARY | Partial Response Rate (PRR) | at 24 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 24 months; therefore, no data was collected. | ||
| SECONDARY | Duration of Response (DOR) | Up to 3 years after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 3 years; therefore, no data was collected. | ||
| SECONDARY | Progression Free Survival (PFS) | at 6 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 6 months, therefore, no data was collected. | ||
| SECONDARY | Progression Free Survival (PFS) | at 12 months after treatment | Due to notification by AstraZeneca to terminate financial support of all research activity not associated with active subjects receiving study medication enrolled under this IND, it has been decided to close the study to enrollment and to cease long-term follow-up of subjects not actively receiving study medication. Participants were unable to be followed after the end of treatment for 12 months; therefore, no data was collected. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab and Acalabrutinib | 6 | |
| Overall Study | COMPLETED | Rituximab and Acalabrutinib | 6 | |
| Overall Study | NOT COMPLETED | Rituximab and Acalabrutinib | 0 |
Source ClinicalTrials.gov
Adverse events31
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 | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Supraventricular tachycardia | Cardiac disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Anal hemorrhage | Gastrointestinal disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Fatigue | General disorders | Rituximab and Acalabrutinib | 3 | 6 | 3 |
| other | Fever | General disorders | Rituximab and Acalabrutinib | 1 | 6 | 1 |
| other | Infections and infestations | Infections and infestations | Rituximab and Acalabrutinib | 1 | 6 | 1 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab and Acalabrutinib | 1 | 6 |
| Total, other adverse events | Rituximab and Acalabrutinib | 3 | 6 |
| Total, serious adverse events | Rituximab and Acalabrutinib | 2 | 6 |
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/NCT04337827
GET https://conductscience.org/api/trials/v1/NCT04337827/events?page=2