Trial · NCT04745832
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
NCT04745832, Phase 3, Terminated, MEI Pharma, Inc.; results first posted 2023-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL). Trials, record NCT04745832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04745832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
- NCT number
- NCT04745832
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 82 participants, actual
- Lead sponsor
- MEI Pharma, Inc.
- Conditions
- Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma
- Interventions
- Zandelisib, Rituximab, Bendamustine, CHOP
- First posted
- 2021-02-09
- Last updated
- 2024-11-04
- Other registries' IDs
- eudract:2020-004199-16
- Results first posted
- 2023-12-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 1 year 7 months | PFS is defined as the time from randomization date until the date of disease progression, or death from any cause |
| Secondary | Overall Response Rate (ORR) | 1 year 7 months | ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period. |
| Secondary | Complete Response Rate (CRR) | 1 year 7 months | CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS). |
| Secondary | Overall Survival | 1 year 7 months | OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date. |
| Secondary | Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) | 1 year 7 months | Measured by the number of Treatment Emergent AEs |
| Secondary | Number of SAEs (Zandelisib When Combined With Rituximab) | 1 year 7 months | Measured by the number of SAEs |
| Secondary | Number of Lab Abnormalities (Zandelisib When Combined With Rituximab) | 1 year 7 months | Measured by the number of laboratory abnormalities |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | 1 year 7 months | A decision was made to terminate this Phase 3 study early due to business reasons. For the 82 subjects enrolled no scans had been collected at the time of termination, therefore no data were analyzed. | ||
| SECONDARY | Overall Response Rate (ORR) | 1 year 7 months | A decision was made to terminate this Phase 3 study early due to business reasons. For the 82 subjects enrolled no scans had been collected at the time of termination, therefore no data were analyzed. | ||
| SECONDARY | Complete Response Rate (CRR) | 1 year 7 months | A decision was made to terminate this Phase 3 study early due to business reasons. For the 84 subjects enrolled no scans had been collected at the time of termination, therefore no data were analyzed. | ||
| SECONDARY | Overall Survival | 1 year 7 months | A decision was made to terminate this Phase 3 study early due to business reasons, therefore no data were collected or analyzed. | ||
| SECONDARY | Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) | 1 year 7 months | Of the 41 subjects enrolled to the R+Zandelisib group 38 had a Treatment Emergent AE Of the 41 subjects enrolled to the R-Chemo group 37 had a Treatment Emergent AE | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of SAEs (Zandelisib When Combined With Rituximab) | 1 year 7 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Lab Abnormalities (Zandelisib When Combined With Rituximab) | 1 year 7 months | A decision was made to terminate this Phase 3 study early due to business reasons. For the 82 subjects enrolled no lab abnormalities had been collected or analyzed |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) | Rituximab Plus Zandelisib | 38 | Participants | ||
| Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) | Rituximab Plus Chemotherapy | 37 | Participants | ||
| Number of SAEs (Zandelisib When Combined With Rituximab) | Rituximab Plus Zandelisib | 12 | Participants | ||
| Number of SAEs (Zandelisib When Combined With Rituximab) | Rituximab Plus Chemotherapy | 8 | 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 | Rituximab Plus Zandelisib | 41 | |
| Overall Study | STARTED | Rituximab Plus Chemotherapy | 41 | |
| Overall Study | COMPLETED | Rituximab Plus Zandelisib | 41 | |
| Overall Study | COMPLETED | Rituximab Plus Chemotherapy | 41 | |
| Overall Study | NOT COMPLETED | Rituximab Plus Zandelisib | 0 | |
| Overall Study | NOT COMPLETED | Rituximab Plus Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events352
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 | Anaemia | Blood and lymphatic system disorders | Rituximab Plus Zandelisib | 1 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab Plus Chemotherapy | 4 | 41 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rituximab Plus Zandelisib | 0 | 41 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rituximab Plus Chemotherapy | 2 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab Plus Zandelisib | 2 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab Plus Chemotherapy | 1 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab Plus Zandelisib | 0 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab Plus Chemotherapy | 2 | 41 | |
| other | Palpitations | Cardiac disorders | Rituximab Plus Zandelisib | 0 | 41 | |
| other | Palpitations | Cardiac disorders | Rituximab Plus Chemotherapy | 1 | 41 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab Plus Zandelisib | 1 | 41 |
| Total, all-cause mortality | Rituximab Plus Chemotherapy | 1 | 41 |
| Total, other adverse events | Rituximab Plus Zandelisib | 38 | 41 |
| Total, other adverse events | Rituximab Plus Chemotherapy | 37 | 41 |
| Total, serious adverse events | Rituximab Plus Zandelisib | 12 | 41 |
| Total, serious adverse events | Rituximab Plus Chemotherapy | 8 | 41 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: Number of SAEs (Zandelisib When Combined With Rituximab) | Trial comparisons |
| Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) | Trial comparisons |
| Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: deaths from any cause | Trial comparisons |
| Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: 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/NCT04745832
GET https://conductscience.org/api/trials/v1/NCT04745832/events?page=2