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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

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.
Select...
I have fluid around my lungs or heart.
Select...
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.
Select...
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 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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Rash
11%
Abdominal pain
10%
Hypokalaemia
10%
Oedema peripheral
9%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Pruritus
7%
Arthralgia
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Pneumonia staphylococcal
1%
Interstitial lung disease
1%
Rash erythematous
1%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Skin infection
1%
Streptococcal sepsis
1%
Accidental overdose
1%
Fungal oesophagitis
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
1%
Respiratory failure
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab

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
~280
Bortezomib
2005
Completed Phase 3
~1410
Fludeoxyglucose F-18
2018
Completed Phase 4
~590
Ofatumumab
2013
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,865 Total Patients Enrolled
Kristie A BlumPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Bendamustine Hydrochloride (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01286272 — Phase 2
Follicular Lymphoma Research Study Groups: Arm A (ofatumumab, bendamustine hydrochloride), Arm B (ofatumumab, bendamustine hydrochloride, bortezomib)
Follicular Lymphoma Clinical Trial 2023: Bendamustine Hydrochloride Highlights & Side Effects. Trial Name: NCT01286272 — Phase 2
Bendamustine Hydrochloride (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01286272 — Phase 2
~9 spots leftby Sep 2025
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