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Alkylating agents

Ofatumumab Combination Therapy for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Francisco Hernandez-ILizaliturri
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through study completion, an average of 5 years
Awards & highlights

Study Summary

This trial is studying how well ofatumumab in combination with other drugs works in treating patients with newly diagnosed mantle cell lymphoma.

Eligible Conditions
  • Mantle Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients Experiencing a Complete Response
Secondary outcome measures
Change From Baseline in Percentage of Cells Positive for Ki67
Median Overall Survival (OS)
Median Progression-free Survival (PFS)
+8 more

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%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Aspartate aminotransferase increased
9%
Dyspnoea
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%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Pneumonia staphylococcal
1%
Enterocolitis
1%
Skin infection
1%
Mental impairment
1%
Upper gastrointestinal haemorrhage
1%
Streptococcal sepsis
1%
Respiratory failure
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia aspiration
1%
Pleural haemorrhage
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

1Treatment groups
Experimental Treatment
Group I: Treatment (monoclonal antibody and combination chemotherapy)Experimental Treatment9 Interventions
COURSES 1, 3, and 5 (O-HyperCVAD): Patients receive ofatumumab IV on day 1, cyclophosphamide IV over 2 hours every 12 hours for 6 doses on days 3-5, doxorubicin hydrochloride IV continuously over 72 hours on days 6-8, vincristine sulfate IV on days 6 and 13, and dexamethasone IV or PO on days 3-6 and 13-16. COURSES 2, 4, and 6 (O-HD-MA): Patients receive ofatumumab IV on day 1, methotrexate IV continuously over 24 hours on day 3, and cytarabine IV over 2 hours every 12 hours on days 4-5. All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo standard HDC-ASCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Dexamethasone
2007
Completed Phase 4
~2590
Cytarabine
2016
Completed Phase 3
~3310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Methotrexate
2013
Completed Phase 4
~3800
Ofatumumab
2013
Completed Phase 3
~1470
Vincristine Sulfate
2005
Completed Phase 3
~10150
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
404 Previous Clinical Trials
31,264 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
116 Previous Clinical Trials
7,755 Total Patients Enrolled
Francisco Hernandez-ILizaliturriPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01527149 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Treatment (monoclonal antibody and combination chemotherapy)
Mantle Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01527149 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01527149 — Phase 2
~3 spots leftby Jun 2025
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