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Alkylating agents

Ofatumumab + Bendamustine +/- Bortezomib for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Kristie A Blum

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Histologically confirmed follicular non-Hodgkin lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat patients with a certain type of lymphoma that has not been treated before.

Who is the study for?

This trial is for adults with untreated follicular non-Hodgkin lymphoma, grades 1-3a. Participants must have certain risk factors like age over 60 or involvement of more than four nodal sites. They should not have had previous cancer treatments and must not be pregnant or nursing, agreeing to use contraception if necessary. People with HIV can join if they meet specific health criteria.

What is being tested?

The study tests how well the combination of ofatumumab and bendamustine hydrochloride works compared to adding bortezomib in treating this type of lymphoma. Ofatumumab targets cancer cells, while bendamustine hydrochloride and bortezomib work to stop cancer growth by killing cells or blocking enzymes needed for cell growth.

What are the potential side effects?

Potential side effects include reactions at the infusion site, low blood counts leading to increased infection risk, fatigue, nausea, nerve damage that may cause pain or numbness (with bortezomib), and liver issues reflected in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My lymphoma is a type of non-Hodgkin's, grades 1, 2, or 3a.

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I have fluid around my lungs or heart.

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My non-Hodgkin lymphoma has spread to my bone marrow.

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My cancer has spread to the lining of my brain and spinal cord.

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I have fluid buildup in my abdomen.

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I do not have skin or lung inflammation from lymph vessel blockage.

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I have 3 or more risk factors for follicular lymphoma, or 2 with a large tumor.

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I haven't had chemotherapy, radiotherapy, or immunotherapy before.

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I have inflammatory breast disease.

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My lymphoma has not spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Complete Response Rate

Secondary study objectives

Progression-free Survival (PFS)

The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment

Other study objectives

Immunohistochemical (IHC) Markers

Pre-treatment Single Nucleotide Polymorphisms (SNP)

Predictive Value of Fludeoxyglucose-positron-emission Tomography

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522

50%

Diarrhoea

34%

Neutropenia

29%

Pyrexia

25%

Anaemia

24%

Nausea

23%

Cough

17%

Thrombocytopenia

17%

Constipation

16%

Fatigue

16%

Pneumonia

15%

Vomiting

15%

Decreased appetite

14%

Upper respiratory tract infection

13%

Asthenia

13%

Colitis

13%

Weight decreased

13%

Bronchitis

11%

Abdominal pain

11%

Rash

10%

Hypokalaemia

10%

Oedema peripheral

Aspartate aminotransferase increased

Dyspnoea

Alanine aminotransferase increased

Back pain

Dizziness

Headache

Hypertension

Nasopharyngitis

Arthralgia

Pruritus

Hyperkalaemia

Respiratory tract infection

Rash maculo-papular

Febrile neutropenia

Rhinorrhoea

Dyspepsia

Pain in extremity

Abdominal pain upper

Dehydration

Insomnia

Productive cough

Dry mouth

Muscle spasms

Paraesthesia

Pneumonitis

Renal failure acute

Toxic skin eruption

Hypotension

General physical health deterioration

Gastroenteritis

Gastritis

Pneumonia pseudomonas aeruginosa

Pancytopenia

Cardiac failure

Sepsis

Pneumocystis jirovecii pneumonia

Pneumonia pneumococcal

Pulmonary embolism

Pneumonia aspiration

Pneumonia klebsiella

Urinary tract infection

Respiratory failure

Pleural haemorrhage

Streptococcal sepsis

Interstitial lung disease

Skin infection

Pneumonia staphylococcal

Rash erythematous

Accidental overdose

Fungal oesophagitis

Upper gastrointestinal haemorrhage

Proctitis

Enterocolitis

Mental impairment

Intestinal adenocarcinoma

Deep vein thrombosis

Haemolytic anaemia

Atrial fibrillation

Cardiac failure congestive

Myocardial infarction

Pericarditis

Death

Mucosal inflammation

Multi-organ failure

Sudden death

Transitional cell carcinoma

Bronchiolitis

Bronchitis viral

Bronchopneumonia

Cytomegalovirus colitis

Pneumonia escherichia

Pneumonia mycoplasmal

Septic shock

Streptococcal bacteraemia

Subdural haematoma

Lipase increased

Nephrolithiasis

Renal colic

Renal failure

Renal failure chronic

Lung disorder

Ventricular tachycardia

Colitis ischaemic

Enteritis

Pancreatitis acute

Ileal ulcer

Aspergillus infection

Bronchopulmonary aspergillosis

Campylobacter gastroenteritis

Clostridium difficile colitis

Fungal infection

Influenza

Pseudomonal sepsis

Lower respiratory tract infection

Pneumonia bacterial

Enterococcal infection

Enterococcal sepsis

Escherichia sepsis

Escherichia urinary tract infection

Gastroenteritis viral

Haemophilus infection

Infection

Infusion site cellulitis

Lobar pneumonia

Lower respiratory tract infection viral

Lung infection

Pneumonia respiratory syncytial viral

Pneumonia streptococcal

Pseudomonas bronchitis

Wound infection staphylococcal

Cervical vertebral fracture

Femur fracture

Traumatic haematoma

Malnutrition

Hyponatraemia

Tumour lysis syndrome

Arthritis

Bone pain

Malignant melanoma

Brain stem haemorrhage

Dementia

Acute respiratory distress syndrome

Acute respiratory failure

Chronic obstructive pulmonary disease

Dermatitis exfoliative

Thrombosis

Infusion related reaction

Neuroendocrine tumour

Pleural effusion

Mallory-Weiss syndrome

Diverticulitis

Pyelonephritis

Haemorrhagic stroke

Dermatitis allergic

Respiratory tract infection bacterial

Splenic rupture

Neuroendocrine carcinoma of the skin

100%

80%

60%

40%

20%

Study treatment Arm

Duvelisib

Ofatumumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (ofatumumab, bendamustine hydrochloride, bortezomib)Experimental Treatment6 Interventions

INDUCTION: Patients receive ofatumumab IV over 2-8 hours on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1 and bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.

Group II: Arm A (ofatumumab, bendamustine hydrochloride)Experimental Treatment5 Interventions

INDUCTION: Patients receive ofatumumab IV over 2-8 hours on day 1 and bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bendamustine Hydrochloride

2011

Completed Phase 2

~330

Bortezomib

2005

Completed Phase 3

~1410