Trial · NCT02303392
Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma
NCT02303392, Phase 1, Completed, Jennifer Woyach; results first posted 2025-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma. Trials, record NCT02303392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02303392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma
- NCT number
- NCT02303392
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- Jennifer Woyach
- Conditions
- Prolymphocytic Leukemia, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
- Interventions
- Selinexor, Ibrutinib, Pharmacological Study, Laboratory Biomarker Analysis
- First posted
- 2014-11-27
- Last updated
- 2025-06-10
- Results first posted
- 2025-06-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose for Selinexor | Day 28 | To determine the maximum tolerated dose for the combination of selinexor and ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia(SLL)/B-cell prolymphocytic leukemia (PLL) or aggressive non-Hodgkin lymphoma (NHL). |
| Primary | Maximum Tolerated Dose for Ibrutinib | Day 28 | To determine the maximum tolerated dose for the combination of selinexor and ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia(SLL)/B-cell prolymphocytic leukemia (PLL) or aggressive non-Hodgkin lymphoma (NHL). |
| Secondary | Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Up to 4 years | Toxicities will be tabulated by type and grade and displayed in summary form. In addition, the number of courses started/completed, number of patients requiring dose reductions, and the reason for going off treatment may be summarized to assess treatment tolerability. |
| Secondary | Clinical Response Defined as Those With CR or PR | Up to 4 years | 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. |
| Secondary | Progression Free Survival (PFS) | Date of study enrollment to disease progression or death, whichever occurs first assessed up to 4 years | Progression Free Survival (PFS): PFS calculated from the date of study enrollment to disease progression or death, whichever occurs first. Patients who do not progress or die will be censored at the time of last contact with response assessment by physical exam and laboratory studies. |
| Secondary | Overall Survival (OS) | Date of study enrollment to death assessed up to 5 years | Overall Survival (OS) calculated from the date of study enrollment to death. Patients who do not die will be censored at the time of last contact. This will be analyzed in each cohort independently |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose for Selinexor | Day 28 | mg | NUMBER | |
| SECONDARY | Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Up to 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Response Defined as Those With CR or PR | Up to 4 years | percentage of patients | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Date of study enrollment to disease progression or death, whichever occurs first assessed up to 4 years | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Date of study enrollment to death assessed up to 5 years | months | MEDIAN | |
| PRIMARY | Maximum Tolerated Dose for Ibrutinib | Day 28 | mg | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose for Selinexor | Treatment (Selinexor, Ibrutinib) | 40 | mg | ||
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Chronic Lymphocytic Leukemia (CLL) | Thrombocytopenia | 6 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Non-Hodgkin Lymphoma (NHL) | Thrombocytopenia | 2 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Chronic Lymphocytic Leukemia (CLL) | Anemia | 2 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Non-Hodgkin Lymphoma (NHL) | Anemia | 4 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Chronic Lymphocytic Leukemia (CLL) | Neutropenia | 4 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Non-Hodgkin Lymphoma (NHL) | Neutropenia | 1 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Chronic Lymphocytic Leukemia (CLL) | Lymphocyte count increased | 3 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Non-Hodgkin Lymphoma (NHL) | Lymphocyte count increased | 1 | Participants | |
| Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher | Chronic Lymphocytic Leukemia (CLL) | Lymphopenia | 1 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chronic Lymphocytic Leukemia (CLL) | 16 | |
| Overall Study | STARTED | Non-Hodgkin Lymphoma (NHL) | 18 | |
| Overall Study | COMPLETED | Chronic Lymphocytic Leukemia (CLL) | 16 | |
| Overall Study | COMPLETED | Non-Hodgkin Lymphoma (NHL) | 18 | |
| Overall Study | NOT COMPLETED | Chronic Lymphocytic Leukemia (CLL) | 0 | |
| Overall Study | NOT COMPLETED | Non-Hodgkin Lymphoma (NHL) | 0 |
Source ClinicalTrials.gov
Adverse events586
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 | Abdominal pain | Gastrointestinal disorders | Chronic Lymphocytic Leukemia (CLL) | 2 | 16 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Non-Hodgkin Lymphoma (NHL) | 3 | 18 | 3 |
| other | Actinic Keratosis | Skin and subcutaneous tissue disorders | Chronic Lymphocytic Leukemia (CLL) | 1 | 16 | 1 |
| other | Actinic Keratosis | Skin and subcutaneous tissue disorders | Non-Hodgkin Lymphoma (NHL) | 0 | 18 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Chronic Lymphocytic Leukemia (CLL) | 3 | 16 | 8 |
| other | Activated partial thromboplastin time prolonged | Investigations | Non-Hodgkin Lymphoma (NHL) | 7 | 18 | 13 |
| other | Otitis media | Infections and infestations | Chronic Lymphocytic Leukemia (CLL) | 1 | 16 | 1 |
| other | Otitis media | Infections and infestations | Non-Hodgkin Lymphoma (NHL) | 0 | 18 | 0 |
| other | Alkaline Phosphatase increased | Investigations | Chronic Lymphocytic Leukemia (CLL) | 5 | 16 | 10 |
| other | Alkaline Phosphatase increased | Investigations | Non-Hodgkin Lymphoma (NHL) | 4 | 18 | 5 |
1 to 10 of 586Source ClinicalTrials.gov
See all 586 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronic Lymphocytic Leukemia (CLL) | 1 | 16 |
| Total, all-cause mortality | Non-Hodgkin Lymphoma (NHL) | 4 | 18 |
| Total, other adverse events | Chronic Lymphocytic Leukemia (CLL) | 16 | 16 |
| Total, other adverse events | Non-Hodgkin Lymphoma (NHL) | 18 | 18 |
| Total, serious adverse events | Chronic Lymphocytic Leukemia (CLL) | 6 | 16 |
| Total, serious adverse events | Non-Hodgkin Lymphoma (NHL) | 7 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35608822 | BACKGROUND |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016058 | Cancer Center Support Grant | RATHMELL, WENDY KIMRYN | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| R01CA192928 | Dual targeting of XPO1 and BTK in B cell malignancies | LAPALOMBELLA, ROSA; BYRD, JOHN C.; WOYACH, JENNIFER A. | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2015 to 2019 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chronic Lymphocytic Leukemia (CLL) vs Non-Hodgkin Lymphoma (NHL): deaths from any cause | Trial comparisons |
| Chronic Lymphocytic Leukemia (CLL) vs Non-Hodgkin Lymphoma (NHL): 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/NCT02303392
GET https://conductscience.org/api/trials/v1/NCT02303392/results?page=2