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Monoclonal Antibodies
Ofatumumab for Graft-versus-Host Disease
Phase 1 & 2
Waitlist Available
Led By Joseph Pidala, MD, MS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hematopoietic cell transplantation (HCT) recipients newly requiring systemic glucocorticoid therapy (at ≥ 1mg/kg/day prednisone or equivalent) for chronic GVHD
Participants can be enrolled and begin study therapy with ofatumumab within 14 days from initiation of 1 mg/kg/day prednisone for therapy of chronic GVHD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This study is evaluating whether a drug called Ofatumumab can be used to treat chronic graft-versus-host disease.
Eligible Conditions
- Graft-versus-Host Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose of Ofatumumab
Participants Response Rates
Secondary outcome measures
Overall Survival (OS) at 24 Months
Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452221%
Neutropenia
18%
Infusion related reaction
14%
Cough
12%
Diarrhoea
12%
Fatigue
12%
Rash
11%
Nausea
11%
Asthenia
10%
Anaemia
10%
Paraesthesia
10%
Pyrexia
8%
Constipation
8%
Headache
8%
Upper respiratory tract infection
8%
Bronchitis
6%
Pruritus
6%
Vomiting
6%
Dyspnoea
6%
Thrombocytopenia
6%
Insomnia
6%
Paraesthesia oral
5%
Hypotension
5%
Back pain
5%
Muscle spasms
5%
Oedema peripheral
3%
Dizziness
3%
Arthralgia
3%
Hypertension
3%
Hyperkalaemia
3%
Pneumonia
3%
Abdominal pain upper
3%
Nasopharyngitis
3%
Decreased appetite
3%
Dyspepsia
2%
Febrile neutropenia
2%
Weight decreased
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Abdominal pain
2%
Hypokalaemia
2%
Rhinorrhoea
2%
Escherichia sepsis
2%
Respiratory tract infection
2%
Pain in extremity
1%
Rash maculo-papular
1%
Colitis
1%
Clostridium difficile infection
1%
Cardiac failure
1%
Productive cough
1%
Dehydration
1%
Neutropenic sepsis
1%
Sepsis
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Lymph node pain
1%
Atrial fibrillation
1%
Disease progression
1%
Cholecystitis
1%
Drug hypersensitivity
1%
Streptococcal bacteraemia
1%
Device related infection
1%
Herpes virus infection
1%
Ischaemic stroke
1%
Renal failure acute
1%
Angina pectoris
1%
Oesophageal ulcer
1%
Portal hypertensive gastropathy
1%
Infusion site extravasation
1%
Hepatic failure
1%
Contrast media allergy
1%
Pneumonia bacterial
1%
Escherichia urinary tract infection
1%
Pneumonia viral
1%
Gastroenteritis
1%
Fall
1%
Hyponatraemia
1%
Hypercalcaemia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Malignant melanoma
1%
Glioblastoma multiforme
1%
Malignant pleural effusion
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of lung
1%
Pulmonary embolism
1%
Laryngeal stenosis
1%
Peripheral embolism
1%
Dry mouth
1%
Tachycardia
1%
Enterocolitis
1%
Lower respiratory tract infection
1%
Chronic sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ofatumumab
Duvelisib
Trial Design
1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment1 Intervention
Phase I:
Escalating dose of ofatumumab
Phase II:
Maximum tolerated dose (MTD) of Ofatumumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,947 Total Patients Enrolled
Joseph Pidala, MD, MSPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
54 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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