Trial · NCT02138786
Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation
NCT02138786, Phase 2, Terminated, Karyopharm Therapeutics Inc; results first posted 2020-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation. Trials, record NCT02138786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation
- NCT number
- NCT02138786
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Richter's Transformation
- Interventions
- selinexor
- First posted
- 2014-05-15
- Last updated
- 2023-01-26
- Results first posted
- 2020-02-11
- Limitations and caveats
The low number of formal objective responses (leading to the termination of the study following the first stage), coupled with the high number of censored observations, limited meaningful analyses and the ability to draw conclusions from the data.
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 With Overall Response (Overall Response Rate) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites. |
| Primary | Number of Participants With Complete Response (CR) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. |
| Primary | Number of Participants With Partial Response (PR) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. |
| Primary | Number of Participants With Stable Disease (SD) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of patients whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. |
| Primary | Number of Participants With Progressive Disease (PD) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of patients whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. |
| Primary | Number of Participants With Not Evaluable (NE) Response | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of patients who could not be assessed quantitatively for disease response for any reason. |
| Secondary | Percentage of Participants With Disease Control (Disease Control Rate) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. |
| Secondary | Duration of Progression Free Survival (PFS) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Patients who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Patients without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. . |
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 With Overall Response (Overall Response Rate) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Complete Response (CR) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Partial Response (PR) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Stable Disease (SD) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Progressive Disease (PD) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Not Evaluable (NE) Response | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Disease Control (Disease Control Rate) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Progression Free Survival (PFS) | Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. | Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population. | Days | MEDIAN |
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 With Overall Response (Overall Response Rate) | Selinexor | 4 | 95% Confidence Interval 0.1 to 20.4 | Percentage of participants | |
| Number of Participants With Complete Response (CR) | Selinexor | 0 | Participants | ||
| Number of Participants With Partial Response (PR) | Selinexor | 1 | Participants | ||
| Number of Participants With Stable Disease (SD) | Selinexor | 6 | Participants | ||
| Number of Participants With Progressive Disease (PD) | Selinexor | 7 | Participants | ||
| Number of Participants With Not Evaluable (NE) Response | Selinexor | 11 | Participants | ||
| Percentage of Participants With Disease Control (Disease Control Rate) | Selinexor | 28.0 | 95% Confidence Interval 12.1 to 49.4 | Percentage of participants | |
| Duration of Progression Free Survival (PFS) | Selinexor | 38.0 | 95% Confidence Interval 22.0 to 86.0 | Days |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selinexor 60 mg/m² (8 Doses/Cycle) | 3 | |
| Overall Study | STARTED | Selinexor 60 mg (6 Doses/Cycle) | 15 | |
| Overall Study | STARTED | Selinexor 60 mg (8 Doses/Cycle) | 8 | |
| Overall Study | COMPLETED | Selinexor 60 mg/m² (8 Doses/Cycle) | 0 | |
| Overall Study | COMPLETED | Selinexor 60 mg (6 Doses/Cycle) | 0 | |
| Overall Study | COMPLETED | Selinexor 60 mg (8 Doses/Cycle) | 0 | |
| Overall Study | NOT COMPLETED | Selinexor 60 mg/m² (8 Doses/Cycle) | 3 | |
| Overall Study | NOT COMPLETED | Selinexor 60 mg (6 Doses/Cycle) | 15 | |
| Overall Study | NOT COMPLETED | Selinexor 60 mg (8 Doses/Cycle) | 8 |
Source ClinicalTrials.gov
Adverse events489
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 60 mg/m² (8 Doses/Cycle) | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Selinexor 60 mg (6 Doses/Cycle) | 8 | 15 | |
| other | Nausea | Gastrointestinal disorders | Selinexor 60 mg (8 Doses/Cycle) | 3 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor 60 mg/m² (8 Doses/Cycle) | 1 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor 60 mg (6 Doses/Cycle) | 5 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor 60 mg (8 Doses/Cycle) | 3 | 8 | |
| other | Vomiting | Gastrointestinal disorders | Selinexor 60 mg/m² (8 Doses/Cycle) | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Selinexor 60 mg (6 Doses/Cycle) | 7 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Selinexor 60 mg (8 Doses/Cycle) | 1 | 8 | |
| other | Constipation | Gastrointestinal disorders | Selinexor 60 mg/m² (8 Doses/Cycle) | 1 | 3 |
1 to 10 of 489Source ClinicalTrials.gov
See all 489 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selinexor 60 mg/m² (8 Doses/Cycle) | 1 | 3 |
| Total, all-cause mortality | Selinexor 60 mg (6 Doses/Cycle) | 8 | 15 |
| Total, all-cause mortality | Selinexor 60 mg (8 Doses/Cycle) | 2 | 8 |
| Total, other adverse events | Selinexor 60 mg/m² (8 Doses/Cycle) | 3 | 3 |
| Total, other adverse events | Selinexor 60 mg (6 Doses/Cycle) | 15 | 15 |
| Total, other adverse events | Selinexor 60 mg (8 Doses/Cycle) | 7 | 8 |
| Total, serious adverse events | Selinexor 60 mg/m² (8 Doses/Cycle) | 3 | 3 |
| Total, serious adverse events | Selinexor 60 mg (6 Doses/Cycle) | 9 | 15 |
| Total, serious adverse events | Selinexor 60 mg (8 Doses/Cycle) | 5 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17242396 | BACKGROUND |
Source PubMed
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/NCT02138786
GET https://conductscience.org/api/trials/v1/NCT02138786/events?page=2