ClinicalTrials.gg
CompletedNCT02303392Updated Jun 10, 2025Results posted

Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma

A Phase 1 interventional study of Selinexor and Ibrutinib in Prolymphocytic Leukemia, Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Mantle Cell Lymphoma, sponsored by Jennifer Woyach. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Jennifer Woyach · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial studies the side effects and best dose of selinexor when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. To characterize the safety and tolerability of the combination of selinexor and ibrutinib in patients with relapsed or refractory CLL/SLL/PLL or aggressive NHL.

II. To characterize the pharmacokinetic (PK) properties of the combination of selinexor and ibrutinib in patients with relapsed or refractory CLL/SLL/PLL or aggressive NHL.

III. To obtain preliminary evidence on efficacy of the combination of selinexor and ibrutinib in patients with relapsed or refractory CLL/SLL/PLL or aggressive NHL.

IV. To obtain preliminary evidence of response in CLL/SLL/PLL and diffuse large B-cell lymphoma (DLBCL) patients receiving the combination of selinexor and ibrutinib as related to CLL/SLL/PLL karyotype and immunoglobulin variable heavy chain (IgVH) mutational status and DLBCL subtype, respectively.

V. To evaluate the inhibition of the B-cell receptor signaling pathway in patients with relapsed or refractory CLL/SLL/PLL who receive the combination of selinexor and ibrutinib.

VI. To evaluate the change in localization of tumor suppressor and growth regulation proteins in patients with relapsed or refractory CLL/SLL/PLL following treatment with selinexor in general and as related to response.

VII. To preliminarily assess potential causes for primary and secondary resistance to selinexor and ibrutinib.

VIII. To measure intracellular levels of selinexor and metabolites in peripheral blood mononuclear cells and to identify how this relates to pharmacodynamics effects and clinical outcomes.

OUTLINE: This is a dose-escalation study of selinexor.

Patients receive ibrutinib orally (PO) on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO twice daily (BID) weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 6 months thereafter.

02

Conditions studied

  • Prolymphocytic Leukemia
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
03

In context

Leukemia, Prolymphocytic

172 studies on the registry are indexed under Leukemia, Prolymphocytic; 5 are open to participants now.

This study's enrollment of 34 is close to the median of 37 across 127 interventional studies indexed under Leukemia, Prolymphocytic.

Browse Leukemia, Prolymphocytic studies →

Lead sponsor

Jennifer Woyach is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A confirmed diagnosis of CLL according the International Workshop on CLL/SLL/B-cell PLL or variant of these (IWCLL or World Health Organization [WHO] Criteria) and meet criteria for treatment or have need for cytoreduction for stem cell transplantation or alternative cell therapy; OR
  • A histologically confirmed diagnosis of mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) de novo or in the setting of transformation from an indolent lymphoma (including DLBCL not otherwise specified) according to the World Health Organization criteria for diagnosis of NHL; AND
  • Patients must have received at least one prior therapy for CLL or NHL, need additional treatment, and meet criteria for disease; they may not be a candidate for curative therapy; relapsed disease is defined as a patient who previously achieved a complete remission (CR) or a partial remission (PR), but after a period of six or more months demonstrates evidence of disease progression; refractory disease is defined as progression within six months of the last anti-leukemic or anti-lymphoma therapy, or any response less than a CR or PR
  • Patients must have an (ECOG) performance status of =\< 2
  • Patients with NHL must have objective, documented evidence of disease prior to study entry
  • count >= 50,000/mm\^3 in the absence of bone marrow involvement; patients with bone marrow involvement only require a platelet count of 30,000/mm\^3
  • >= 1000/mm\^3 in the absence of bone marrow involvement
  • (as calculated by Cockroft Gault equation = [140-age] * mass [kg]/[72 * creatinine mg/dL) >= 30mL/min
  • (AST)/alanine aminotransferase (ALT) \< 2.5 times (ULN)
  • Total =\< 2.0 x ULN
  • Female patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective method during the course of the study and for 2 months following the completion of their last treatment
  • Female of must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test result within 3 days of first study dose; female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have beta-HCG pregnancy test waived
  • Patients who are polymerase chain reaction (PCR) negative who have a recent (\< 6 month) history of intravenous immunoglobulin (IVIG) therapy are eligible; patients with a history of hepatitis B (surface antigen or core antibody positive and PCR positive) must take lamivudine or equivalent drug during study therapy and for one year after completion of all therapy; patients on IVIG who are core antibody positive but PCR negative are not mandated to take prophylaxis
  • Ability to understand and the willingness to sign a written document

Exclusion criteria

Exclusion Criteria:

  • Patients who are concurrently receiving any other agents
  • Patients who have received:

    • Radiation or chemotherapy =\< 4 weeks
    • Mitomycin C, nitrosureas, or radio-immunotherapy =\< 6 weeks, or
    • Immunotherapy or targeted therapy (such as kinase inhibitors) =\< 2 weeks prior to cycle 1 day 1(except patients already on ibrutinib)
    • Palliative for disease related symptoms are allowed as long as dose is tapered down to an equivalent of =\< 10 mg of oral prednisone daily on cycle 1 day 1
  • Patients who have underwent or allogeneic stem cell transplant =\< 4 weeks prior to cycle 1 day 1 or have active are excluded
  • Patients unable to swallow capsules, those with uncontrolled vomiting or diarrhea or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as: malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine
  • Patients who are 20% below their ideal body weight
  • Patients must not be receiving systemic anticoagulation with warfarin; patients must be off warfarin for 30 days prior to enrollment; patients who require anticoagulation with an agent other than warfarin will not be excluded, but must be reviewed by the principal investigator prior to enrollment
  • As ibrutinib is extensively metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (/5), and patients must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5
  • Patients with active (HIV) or or C
  • Patients with secondary that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity of selinexor; (Note: patients with basal or squamous skin carcinoma, cervical carcinoma in situ, localized breast cancer requiring hormonal therapy or localized prostate cancer (Gleason score \< 5 are allowed)
  • Patients with active known central nervous system (CNS) involvement of CLL or lymphoma; (patients with history of CNS CLL or lymphoma now in remission are eligible for the trial)
  • Patients who are pregnant or breast feeding; breastfeeding should be discontinued if the mother is treated with selinexor
  • Patients must have recovered all toxicities from prior therapy or radiation to grade 1 or less (excluding alopecia)
  • Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin , or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with markedly decreased visual acuity
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Treatment (selinexor, ibrutinib)

    Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: Selinexor · Drug: Ibrutinib · Other: Pharmacological Study · Other: Laboratory Biomarker Analysis

Interventions

  • Given PO

    Also known as: CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330

  • Given PO

    Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

  • OtherPharmacological Study

    Correlative studies

    Also known as: pharmacological studies

  • OtherLaboratory Biomarker Analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose for Selinexor

    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).

    Time frame: Day 28

  2. Maximum Tolerated Dose for Ibrutinib

    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).

    Time frame: Day 28

Secondary outcomes

  1. Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher

    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.

    Time frame: Up to 4 years

  2. Clinical Response Defined as Those With CR or PR

    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.

    Time frame: Up to 4 years

  3. Progression Free Survival (PFS)

    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.

    Time frame: Date of study enrollment to disease progression or death, whichever occurs first assessed up to 4 years

  4. Overall Survival (OS)

    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

    Time frame: Date of study enrollment to death assessed up to 5 years

07

Results

Posted Jun 10, 2025

Participant flow

Patients were recruited from June 2015 until July 2019

Participant flow — Overall Study
MilestoneChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Started1618
Completed1618
Not completed00

Outcome measures

PrimaryMaximum Tolerated Dose for Selinexor

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).

Time frame:
Day 28
Reported as:
Number · mg
Maximum Tolerated Dose for Selinexor
mgTreatment (Selinexor, Ibrutinib)
Maximum Tolerated Dose for Selinexor40
SecondaryNumber of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher

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.

Time frame:
Up to 4 years
Reported as:
Count of participants · Participants
Number of Participants With Toxicities Graded by CTCAE V4 That Are Grade 3 or Higher
ParticipantsChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Thrombocytopenia62
Anemia24
Neutropenia41
Lymphocyte count increased31
Lymphopenia16
Nausea10
Diarrhea11
Hypertension54
Joint/Bone Pain10
Hyponatremia32
Pneumonia12
Hyperglycemia11
Fall20
Cataract11
Cognitive Disturbance10
Hypophosphatemia12
Death12
Hypoxia02
SecondaryClinical Response Defined as Those With CR or PR

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.

Time frame:
Up to 4 years
Reported as:
Number · percentage of patients
Clinical Response Defined as Those With CR or PR
percentage of patientsChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Clinical Response Defined as Those With CR or PR4422
SecondaryProgression Free Survival (PFS)

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.

Time frame:
Date of study enrollment to disease progression or death, whichever occurs first assessed up to 4 years
Reported as:
Median · months
Progression Free Survival (PFS)
monthsChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Progression Free Survival (PFS)8.9 (3.9 to 16.1)2.7 (0.7 to 5.4)
SecondaryOverall Survival (OS)

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

Time frame:
Date of study enrollment to death assessed up to 5 years
Reported as:
Median · months
Overall Survival (OS)
monthsChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Overall Survival (OS)58.9 (19.6 to 58.9)5.1 (3.0 to 14.8)
PrimaryMaximum Tolerated Dose for Ibrutinib

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).

Time frame:
Day 28
Reported as:
Number · mg
Maximum Tolerated Dose for Ibrutinib
mgTreatment (Selinexor, Ibrutinib)
Maximum Tolerated Dose for Ibrutinib420

Adverse events

Collected over All patients must be carefully monitored for AEs, including clinical laboratory tests. AEs should be assessed in terms of their seriousness, intensity, and relationship to the study drug. For consistency, events are to be graded using the CTCAE version 4.0 from start of study to completion for up to 4 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Lymphocytic Leukemia (CLL)1/16 (6.3%)6/16 (37.5%)16/16 (100%)
Non-Hodgkin Lymphoma (NHL)4/18 (22.2%)7/18 (38.9%)18/18 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
FallInjury, poisoning and procedural complications2/160/18
Lung InfectionInfections and infestations1/162/18
Death, NOSGeneral disorders1/162/18
HypercalcemiaMetabolism and nutrition disorders0/162/18
SepsisInfections and infestations0/162/18
PneumonitisRespiratory, thoracic and mediastinal disorders1/160/18
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders1/160/18
Back PainMusculoskeletal and connective tissue disorders1/160/18
Acute Kidney InjuryRenal and urinary disorders1/160/18
PalpitationsCardiac disorders1/160/18
Most frequent other events
Showing 10 of 269
Most frequent other events
EventChronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)
Platelet count decreasedInvestigations15/1613/18
AnemiaBlood and lymphatic system disorders14/1614/18
HypertensionVascular disorders12/1615/18
FatigueGeneral disorders13/1613/18
CoughRespiratory, thoracic and mediastinal disorders11/167/18
Lymphocyte count increasedInvestigations11/164/18
NauseaGastrointestinal disorders11/1611/18
DiarrheaGastrointestinal disorders9/1610/18
AnorexiaMetabolism and nutrition disorders8/1610/18
ConstipationGastrointestinal disorders5/1610/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)Total
<=18 years000
Between 18 and 65 years11617
>=65 years51217
Sex: Female, Male
Sex: Female, Male(Participants)Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)Total
Female5611
Male111223
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White161834
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)Total
United States161834
Number of prior therapies
Number of prior therapies(Participants)Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin Lymphoma (NHL)Total
1325
2213
3-8111021
10-14055
08

Study locations

2 sites
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
09

References and documents

Publications

  • Stephens DM, Huang Y, Ruppert AS, Walker JS, Canfield D, Cempre CB, Fu Q, Baker S, Hu B, Shah H, Vadeboncoeur R, Rogers KA, Bhat S, Jaglowski SM, Lockman H, Lapalombella R, Byrd JC, Woyach JA. Selinexor Combined with Ibrutinib Demonstrates Tolerability and Safety in Advanced B-Cell Malignancies: A Phase I Study. Clin Cancer Res. 2022 Aug 2;28(15):3242-3247. doi: 10.1158/1078-0432.CCR-21-3867. PubMed 35608822 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Apr 2022, 82 months.

Results were first posted in Jun 2025, 3 years 1 month after primary completion.

Of 10 phase 1 interventional studies under Leukemia, Prolymphocytic, half reached primary completion within 64 months of starting (the median); a quarter within 39 and three quarters within 82. This study's 82 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2014
First posted
Nov 27, 2014
StartActual
Jun 9, 2015
Primary completionActual
Apr 18, 2022
CompletionActual
Apr 18, 2022
Results first posted
Jun 10, 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02303392
Lead sponsor
Jennifer Woyach
Responsible party
Jennifer Woyach (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Sponsor-investigator
First posted
Nov 27, 2014
Start date
Jun 9, 2015
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Results posted
Jun 10, 2025
Last update
Jun 10, 2025

Study contacts

Jennifer Woyach, MD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Selinexor

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