Trial · NCT02314247
Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
NCT02314247, Phase 2, Terminated, Karyopharm Therapeutics Inc; results first posted 2018-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma. Trials, record NCT02314247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02314247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
- NCT number
- NCT02314247
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL)
- Interventions
- Selinexor
- First posted
- 2014-12-11
- Last updated
- 2023-01-26
- Results first posted
- 2018-08-20
- Limitations and caveats
Due to unexpectedly slow recruitment, the Sponsor decided to terminate the study after 16 patients had been enrolled. The small study population limits the evaluation of both efficacy and safety of selinexor in patients with PTCL or CTCL.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. |
| Primary | Best Overall Response: Complete Response (CR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Patients who achieved CR (disappearance of all detectable evidence of disease). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Primary | Best Overall Response: Partial Response (PR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Patients whose best overall response to study treatment was PR (regression of measurable disease and no new sites). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Primary | Best Overall Response: Stable Disease (SD) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Patients whose best overall response to study treatment was SD (failure to attain criteria needed for CR or PR, or to meet criteria for PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Primary | Best Overall Response: Progressive Disease (PD) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Patients whose best overall response to study treatment was PD. Progression was defined as the first occurrence of progressive disease (PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. |
| Primary | Best Overall Response: Not Evaluable (NE) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Patients who could not be assessed quantitatively for disease response for any reason. |
| Secondary | Duration of Stable Disease, Including Patients With Partial Response | Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment. | Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Secondary | Disease Control Rate (DCR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Percentage of patients who have CR, PR, or SD lasting ≥ 8 weeks. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Secondary | Progression Free Survival (PFS) | Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment. | Duration of time from start of study treatment to date of disease progression or death from any cause. |
Source ClinicalTrials.gov
Outcomes9
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) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy. | Percentage of participants | NUMBER |
| PRIMARY | Best Overall Response: Complete Response (CR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Best Overall Response: Partial Response (PR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat (ITT) population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Best Overall Response: Stable Disease (SD) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Best Overall Response: Progressive Disease (PD) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Best Overall Response: Not Evaluable (NE) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Stable Disease, Including Patients With Partial Response | Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment. | Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population | Days | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. | Intent to Treat (ITT) Population | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment. | Intent to Treat population. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Selinexor (PTCL) | 11.1 | 80% Confidence Interval 1.2 to 36.8 | Percentage of participants | |
| Overall Response Rate (ORR) | Selinexor (CTCL) | 14.3 | 80% Confidence Interval 1.5 to 45.3 | Percentage of participants | |
| Best Overall Response: Complete Response (CR) | Selinexor (PTCL) | 0 | Participants | ||
| Best Overall Response: Complete Response (CR) | Selinexor (CTCL) | 0 | Participants | ||
| Best Overall Response: Partial Response (PR) | Selinexor (PTCL) | 1 | Participants | ||
| Best Overall Response: Partial Response (PR) | Selinexor (CTCL) | 1 | Participants | ||
| Best Overall Response: Stable Disease (SD) | Selinexor (PTCL) | 2 | Participants | ||
| Best Overall Response: Stable Disease (SD) | Selinexor (CTCL) | 4 | Participants | ||
| Best Overall Response: Progressive Disease (PD) | Selinexor (PTCL) | 2 | Participants | ||
| Best Overall Response: Progressive Disease (PD) | Selinexor (CTCL) | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selinexor (PTCL) | 9 | |
| Overall Study | STARTED | Selinexor (CTCL) | 6 | |
| Overall Study | STARTED | Selinexor (CTCL) 8 Doses/Cycle | 1 | |
| Overall Study | COMPLETED | Selinexor (PTCL) | 0 | |
| Overall Study | COMPLETED | Selinexor (CTCL) | 0 | |
| Overall Study | COMPLETED | Selinexor (CTCL) 8 Doses/Cycle | 0 | |
| Overall Study | NOT COMPLETED | Selinexor (PTCL) | 9 | |
| Overall Study | NOT COMPLETED | Selinexor (CTCL) | 6 | |
| Overall Study | NOT COMPLETED | Selinexor (CTCL) 8 Doses/Cycle | 1 |
Source ClinicalTrials.gov
Adverse events122
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 | Nausea | Gastrointestinal disorders | Selinexor (PTCL) | 5 | 9 | |
| other | Nausea | Gastrointestinal disorders | Selinexor (CTCL) | 5 | 7 | |
| other | Constipation | Gastrointestinal disorders | Selinexor (PTCL) | 1 | 9 | |
| other | Constipation | Gastrointestinal disorders | Selinexor (CTCL) | 4 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor (PTCL) | 2 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor (CTCL) | 1 | 7 | |
| other | Vomiting | Gastrointestinal disorders | Selinexor (PTCL) | 2 | 9 | |
| other | Vomiting | Gastrointestinal disorders | Selinexor (CTCL) | 1 | 7 | |
| other | Dry Mouth | Gastrointestinal disorders | Selinexor (PTCL) | 1 | 9 | |
| other | Dry Mouth | Gastrointestinal disorders | Selinexor (CTCL) | 0 | 7 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selinexor (PTCL) | 3 | 9 |
| Total, all-cause mortality | Selinexor (CTCL) | 1 | 7 |
| Total, other adverse events | Selinexor (PTCL) | 9 | 9 |
| Total, other adverse events | Selinexor (CTCL) | 7 | 7 |
| Total, serious adverse events | Selinexor (PTCL) | 8 | 9 |
| Total, serious adverse events | Selinexor (CTCL) | 1 | 7 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selinexor (PTCL) vs Selinexor (CTCL): Best Overall Response: Not Evaluable (NE) | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): Best Overall Response: Progressive Disease (PD) | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): Best Overall Response: Partial Response (PR) | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): Best Overall Response: Stable Disease (SD) | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): deaths from any cause | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): Best Overall Response: Complete Response (CR) | Trial comparisons |
| Selinexor (PTCL) vs Selinexor (CTCL): 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/NCT02314247
GET https://conductscience.org/api/trials/v1/NCT02314247/events?page=2