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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

No Placebo-Only Group

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 below

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I have DLBCL or low grade B cell lymphoma and have only used steroids for a short period.

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I am mostly self-sufficient and can carry out daily activities.

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I have advanced B-cell NHL and R-CHOP is suitable for me.

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I have at least one tumor that can be measured, or my cancer is stage 4.

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I have been newly diagnosed with advanced stage diffuse large B cell lymphoma.

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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:

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I have severe allergies to the drugs used in this study.

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I do not have any severe ongoing illnesses that would interfere with the study.

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I have not had major surgery within the last 2 weeks.

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I can swallow tablets and don't have GI issues affecting medication absorption.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Blood uric acid increased

Embolism

Haemoglobin decreased

Cardiac failure acute

Pulmonary contusion

Peripheral swelling

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met