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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
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.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have fluid buildup in my abdomen.
Select...
I do not have skin or lung inflammation from lymph vessel blockage.
Select...
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.
Select...
I have inflammatory breast disease.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Secondary outcome measures
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 outcome measures
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 • NCT0200452250%
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%
Abdominal pain
11%
Rash
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 klebsiella
1%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Mental impairment
1%
Pneumonia staphylococcal
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
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
~230
Bortezomib
2005
Completed Phase 2
~1140
Fludeoxyglucose F-18
2018
Completed Phase 2
~550
Ofatumumab
2013
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,018 Total Patients Enrolled
Kristie A BlumPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I am not pregnant or nursing and will use effective birth control during the study.I have cancer that has spread to my bones.My lymphoma is a type of non-Hodgkin's, grades 1, 2, or 3a.I have fluid around my lungs or heart.My non-Hodgkin lymphoma has spread to my bone marrow.I am not on corticosteroids, except for low-dose maintenance or to prevent specific treatment reactions.My cancer has spread to the lining of my brain and spinal cord.My diagnosis was not based only on a bone marrow biopsy.My condition is considered high-risk based on specific indicators.I have fluid buildup in my abdomen.I do not have skin or lung inflammation from lymph vessel blockage.I have HIV with no hepatitis, a CD4+ count over 400, undetectable viral load, no AIDS history, and I'm not on zidovudine or stavudine.I have 3 or more risk factors for follicular lymphoma, or 2 with a large tumor.I haven't had chemotherapy, radiotherapy, or immunotherapy before.I don't have active hepatitis B or C.I have inflammatory breast disease.My lymphoma has not spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (ofatumumab, bendamustine hydrochloride)
- Group 2: Arm B (ofatumumab, bendamustine hydrochloride, bortezomib)
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.
What conditions is Ofatumumab typically utilized to treat?
"Patients with Hodgkin's Disease, Multiple sclerosis, and those who are resistant to Fludarabine and Alemtuzumab have demonstrated a positive response to Ofatumumab."
Answered by AI
Have any other investigations been conducted utilizing Ofatumumab?
"In 2004, the National Institutes of Health Clinical Center conducted the inaugural research into ofatumumab. Since then, a grand total 1136 studies have been finished and 239 are currently underway; many in Goldsboro, North carolina."
Answered by AI
Are there multiple sites offering access to this clinical research?
"This trial is available at 96 medical facilities, such as Wayne Memorial Hospital in Goldsboro, Fort Wayne Medical Oncology and Hematology Inc-Parkview in Fort Wayne, and North Shore University Hospital in Manhasset."
Answered by AI
How many participants are being monitored in this research project?
"This clinical trial has concluded its recruitment phase. Initially posted on April 8th 2011 and last updated 7/27/2022, those looking for other studies can find 1,718 studies actively recruiting patients with lymphoma follicular and 239 more trials utilizing Ofatumumab currently enrolling participants."
Answered by AI
Is there potential for harm to patients when administering Ofatumumab?
"Our team at Power rate the safety of Ofatumumab to be a 2. This is due to Phase 2 clinical trials, which have demonstrated some level of safety but haven't yet proven efficacy in human studies."
Answered by AI
Are there any vacancies left for participants of this experiment?
"At the moment, this clinical trial is not currently recruiting. According to its initial posting date of April 8th 2011 and last update on July 27th 2022, it appears that enrollment has closed. However, if you're looking for other trials with similar criteria there are 1718 studies actively admitting individuals with lymphoma follicular cancer and 239 involving Ofatumumab which remain open to applicants."
Answered by AI
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