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Selective Inhibitor of Nuclear Export
Selinexor + Chemotherapy for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Led By Dipenkumar Modi, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Allowed prior therapy: Newly diagnosed DLBCL and low grade B cell lymphoma: No prior therapy is allowed except steroids equivalent to maximum of prednisone 20 mg once daily for maximum of seven days prior to registration
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to treat B cell Non-Hodgkin's lymphoma. The investigators will establish the maximum tolerated dose of the combination and study its efficacy.
Who is the study for?
This trial is for adults with advanced B-cell non-Hodgkin lymphoma, including newly diagnosed and first relapse patients. It's suitable for those who haven't had anthracycline chemotherapy before or have only used non-anthracycline therapy once. Participants must be in good physical condition (ECOG <=1), not pregnant, willing to use contraception, and have a life expectancy over 6 months.Check my eligibility
What is being tested?
The trial tests Selinexor combined with R-CHOP chemotherapy to find the safest dose and see if it's more effective against B-cell non-Hodgkin lymphoma than standard treatments. The study includes two phases: Phase Ib determines the maximum tolerated dose of Selinexor; Phase II assesses its effectiveness.See study design
What are the potential side effects?
Selinexor may cause nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea or constipation. Chemotherapy side effects can include hair loss, anemia (low red blood cell count), risk of infection due to low white blood cells, bruising or bleeding from low platelets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have DLBCL or low grade B cell lymphoma and have only used steroids for a short period.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I have advanced B-cell NHL and R-CHOP is suitable for me.
Select...
I have at least one tumor that can be measured, or my cancer is stage 4.
Select...
I have been newly diagnosed with advanced stage diffuse large B cell lymphoma.
Select...
My condition is either double hit or transformed diffuse large B cell lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of selinexor in combination with RCHOP chemotherapy defined as =< 1/6 patients experience a dose limiting toxicity (Phase Ib)
Progression-free survival (PFS) for patients with newly diagnosed DLBCL treated with RCHOP-selinexor combination (Phase II)
Secondary outcome measures
CR of patients with newly DLBCL treated with selinexor and RCHOP
Change in CRM1/XPO-1 activity expression assessed in tissue by immunohistochemistry (IHC)
Change in CRM1/XPO-1 activity expression assessed in tissue by polymerase chain reaction (PCR)
+4 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor, RCHOP)Experimental Treatment1 Intervention
Patients will receive selinexor PO on days 1, 8, and 15 of a 21 week cycle. RCHOP will be given at standard dosing every 21 days. In the phase 1 part there is dose escalation for Selinexor in a 3+3 design. Treatment will be given for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with partial response or better will receive maintenance selinexor PO on days 1, 8, 15, and 22 every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,187 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,836 Total Patients Enrolled
Dipenkumar Modi, M.D.Principal Investigator - Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
3 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes (ALT and AST) are more than 2.5 times the normal level.If you have HIV, active hepatitis B, or active hepatitis C, you cannot participate.Your body has too few infection-fighting white blood cells.Your platelet count is less than 100,000 per cubic millimeter.Your bilirubin levels in the blood are higher than normal, unless you have Gilbert's syndrome and your bilirubin levels are very high.Your kidneys are not working well, and this is measured by a formula called the Cockroft and Gault equation.I am mostly self-sufficient and can carry out daily activities.I have severe allergies to the drugs used in this study.I have newly diagnosed DLBCL or low grade B cell NHL, or it's my first relapse after non-anthracycline chemo.I have a low-grade B cell lymphoma such as follicular, marginal zone, indolent mantle cell lymphoma, or Waldenstrom's macroglobulinemia.I have not had major surgery within the last 2 weeks.I have at least one tumor that can be measured, or my cancer is stage 4.I am using effective birth control methods if I can have children.It's been 2 weeks since my last chemo or immunotherapy, or 12 weeks since my radio-immunotherapy.I can swallow tablets and don't have GI issues affecting medication absorption.I have advanced B-cell NHL and R-CHOP is suitable for me.I have DLBCL or low grade B cell lymphoma and have only used steroids for a short period.I have low grade B cell lymphoma and have had one treatment that didn't include anthracycline.I do not have any severe ongoing illnesses that would interfere with the study.I have been newly diagnosed with advanced stage diffuse large B cell lymphoma.You have a strong negative reaction to glucocorticoid medications.I do not have brain metastases.My condition is either double hit or transformed diffuse large B cell lymphoma.You are expected to live for at least 6 more months.I have DLBCL and have had chemotherapy or immunotherapy, or I have low grade B cell lymphoma and had more than one chemotherapy or any treatment with anthracyclines.You are currently taking any other experimental medications.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selinexor, RCHOP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study pioneering a new methodology?
"Presently, 259 cities across 28 countries are hosting 48 ongoing clinical trials for Selinexor. According to records, Karyopharm Therapeutics Inc first began testing the efficacy of this drug in 2014 with an inaugural study that included 16 participants and culminated in a successful Phase 1 approval stage. Since then, 29 additional studies have been finalized."
Answered by AI
What are the research objectives of this investigation?
"The primary objective of this trial is to assess the maximum tolerated dose of selinexor when combined with RCHOP chemotherapy. This will be measured by studying if 1/6 or less patients experience a dose limiting toxicity over 2 years from baseline. Secondary goals include measuring overall survival, response rate and change in CRM1/XPO-1 activity expression through immunohistochemistry (IHC) assessments at baseline and 48-72 hours after cycle 1 day 1 of therapy."
Answered by AI
Has research involving Selinexor been conducted previously?
"48 clinical trials are currently being conducted on Selinexor, 4 of which having reached the Phase 3 stage. While the majority of these studies originate from Bethesda, Maryland, 922 sites across the world have been employed to conduct them."
Answered by AI
How many trial participants are there in total?
"Affirmative. The evidence on clinicaltrials.gov ensures that this trial, which started June 20th 2017, is inviting applicants. Approximately 44 individuals need to be recruited between 2 sites for the study's completion."
Answered by AI
Are there opportunities to join this experiment right now?
"The information on clinicaltrials.gov indicates that recruitment for this medical research is ongoing; the trial was initially posted in June 20th 2017 and last revised on January 10 2022."
Answered by AI
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