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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%)
Must not have
History of severe allergic reactions (as determined by treating physician) attributed to the drugs being used in the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (New York Heart Association [NYHA] class >= 3 or left ventricular ejection fraction < 45%), unstable angina pectoris, myocardial infarction within the last 3 months, clinically significant cardiac arrhythmia (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular [AV] block or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB] permissible), or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe allergies to the drugs used in this study.
Select...
I do not have any severe ongoing illnesses that would interfere with the study.
Select...
I have not had major surgery within the last 2 weeks.
Select...
I can swallow tablets and don't have GI issues affecting medication absorption.
Select...
I do not have brain metastases.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 2022 Phase 3 trial • 402 Patients • NCT0311056243%
Weight decreased
29%
Decreased appetite
29%
Nausea
29%
Cough
29%
Thrombocytopenia
21%
Constipation
21%
Diarrhoea
21%
Anaemia
21%
Fatigue
14%
Neuropathy peripheral
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
14%
Oedema peripheral
14%
Pneumonia
7%
Peripheral swelling
7%
Non-cardiac chest pain
7%
Infection
7%
Bronchiectasis
7%
Lower respiratory tract infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Back pain
7%
Pain in extremity
7%
Fungal skin infection
7%
Respiratory syncytial virus infection
7%
Pharyngitis
7%
Asthma
7%
Haemorrhagic transformation stroke
7%
Urinary tract infection
7%
Basal cell carcinoma
7%
Skin lesion
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Disturbance in attention
7%
Hyponatraemia
7%
Hypophagia
7%
Oropharyngeal pain
7%
Hypertension
7%
Viral infection
7%
C-reactive protein increased
7%
Muscular weakness
7%
Taste disorder
7%
Neutropenia
7%
Pyrexia
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Cardiac failure
7%
Hyperthyroidism
7%
Hepatitis
7%
Mental status changes
7%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone
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 3
~1730
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
164 Previous Clinical Trials
9,179 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,931 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.
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