Trial · NCT03070964
A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma
NCT03070964, Phase 2, Terminated, PharmaMar; results first posted 2020-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma. Trials, record NCT03070964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03070964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma
- NCT number
- NCT03070964
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- PharmaMar
- Conditions
- Lymphoma
- Interventions
- plitidepsin
- First posted
- 2017-03-06
- Last updated
- 2020-10-14
- Results first posted
- 2020-10-14
- Limitations and caveats
On 14May18, Sponsor informed to the sites and IPs its decision to close the recruitment. Study was terminated before reaching the target enrollment due to slow patient accrual and the negative opinion of the EMA-refusal of the mark. auth. plitidepsin
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate by the Lugano Classification Per Independent Review Assessment | Change from Baseline to assessments at: 1/2 weeks after cycle 3 and 4-8 weeks after cycle 6 (1cycle =28days), follow-up every 4 months +/- 2 weeks until progression disease or end of study (expected: 42 months) | The study protocol established that the analysis of the primary endpoint should have been done once a total of 60 patients have received plitidepsin, with two futility analyses planned after the inclusion of approximately 15 and 30 patients, respectively. However, only a total of 14 patients were included, of whom 13 were treated, and 12 were evaluable for the primary efficacy endpoint (ORR per IRC in the "Per Protocol Patients" population). As a result of slow patient accrual, the study was closed before reaching the target enrollment of 15 patients for the first futility analysis, and the primary endpoint (ORR according to the Lugano classification criteria and per IRC) was not assessed. |
| Secondary | Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | From the date when the remission criteria are fulfilled to the first date when progressive disease, recurrence or death (due to any cause)is documented, expected at a maximum of 42 months | CI, confidence interval; CR, complete response; NE, not evaluable; ORR, overall response rate; PD, disease progression; PR, partial response; SD, stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate by the Lugano Classification Per Independent Review Assessment | Change from Baseline to assessments at: 1/2 weeks after cycle 3 and 4-8 weeks after cycle 6 (1cycle =28days), follow-up every 4 months +/- 2 weeks until progression disease or end of study (expected: 42 months) | Justification: The study was closed before reaching the target enrollment of 15 patients for the first futility analysis, and the primary endpoint (ORR according to the Lugano classification criteria and per IRC) was not assessed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | From the date when the remission criteria are fulfilled to the first date when progressive disease, recurrence or death (due to any cause)is documented, expected at a maximum of 42 months | A patient was never treated with plitidepsin. A patient due to lack of AITL diagnosis confirmation | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate by the Lugano Classification Per Independent Review Assessment | Plitidepsin | NA | Participants | ||
| Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | Plitidepsin | CR | 1 | Participants | |
| Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | Plitidepsin | PR | 1 | Participants | |
| Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | Plitidepsin | SD | 1 | Participants | |
| Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | Plitidepsin | PD | 7 | Participants | |
| Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population | Plitidepsin | NE | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plitidepsin | 14 | |
| Overall Study | COMPLETED | Plitidepsin | 0 | |
| Overall Study | NOT COMPLETED | Plitidepsin | 14 |
Source ClinicalTrials.gov
Adverse events78
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 | Subclavian vein thrombosis | Vascular disorders | Plitidepsin | 1 | 13 | 1 |
| other | Asthenia/Fatigue | General disorders | Plitidepsin | 4 | 13 | 6 |
| other | Chills | General disorders | Plitidepsin | 1 | 13 | 2 |
| other | Malaise | General disorders | Plitidepsin | 1 | 13 | 1 |
| other | Oedema peripheral | General disorders | Plitidepsin | 3 | 13 | 3 |
| other | Pyrexia | General disorders | Plitidepsin | 6 | 13 | 17 |
| other | Insomnia | Psychiatric disorders | Plitidepsin | 1 | 13 | 1 |
| other | Limb injury | Injury, poisoning and procedural complications | Plitidepsin | 1 | 13 | 1 |
| other | Alanine aminotransferase increased | Investigations | Plitidepsin | 4 | 13 | 15 |
| other | Aspartate aminotransferase increased | Investigations | Plitidepsin | 1 | 13 | 2 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plitidepsin | 7 | 13 |
| Total, other adverse events | Plitidepsin | 13 | 13 |
| Total, serious adverse events | Plitidepsin | 9 | 13 |
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/NCT03070964
GET https://conductscience.org/api/trials/v1/NCT03070964/events?page=2