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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
Patients with other mantle cell histologies are eligible regardless of stage
No prior radiation therapy for mantle cell lymphoma
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Patients with different types of mantle cell cancer, regardless of its stage, can participate in the study.
Select...
You have not received radiation therapy before for mantle cell lymphoma.
Select...
You are not allergic to mouse-related products.

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
21%
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: 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
Vincristine Sulfate
2005
Completed Phase 3
~10120
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Methotrexate
2013
Completed Phase 4
~3800
Cyclophosphamide
1995
Completed Phase 3
~3780
Ofatumumab
2013
Completed Phase 3
~1470
Cytarabine
2016
Completed Phase 3
~3310
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,477 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,598 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what illnesses is ofatumumab most frequently prescribed?

"Ofatumumab is a widely accepted treatment for Kaposi's Sarcoma associated with AIDS. It has also been used to address various other medical issues, such as Leukemia, Synovitis, Ophthalmia and Sympathetic conditions."

Answered by AI

What have been the findings regarding Ofatumumab's safety and efficacy?

"Ofatumumab has only been through a Phase 2 trial, so its safety rating is set at 2. This means there are some data pointing to it being safe, but none that prove efficacy yet."

Answered by AI

Is this clinical trial currently accepting new participants?

"Regrettably, this clinical trial is not presently admitting new participants. It was initially posted on December 6th 2011 and last updated March 9th 2022. However, there are an abundance of other medical studies with open recruitment processes; 1720 trials require noncontiguous stage ii mantle cell lymphoma patients while a further 1,705 currently search for Ofatumumab qualified candidates."

Answered by AI

Do I qualify to partake in this trial?

"For acceptance into this trial, eligible patients must have stage two mantle cell lymphoma and be between 18-70 years old. The team is aiming to recruit a total of 37 individuals for the study."

Answered by AI

What precedent has been established with regards to research on Ofatumumab?

"Ofatumumab was first trialled in Spectrum Health Hospital - Butterworth Campus back in 1997, with 3648 completed studies to date. Presently there are 1705 active clinical trials across the United States of America, many being conducted in Buffalo, New york."

Answered by AI

Is this experiment an unprecedented venture in its field?

"Currently, there are 1705 active studies of Ofatumumab taking place across 85 different nations and 3086 cities. The initial study for this drug began in 1997 under the sponsorship of Alfacell; it included 300 individuals and achieved Drug Approval Phase 3 status. Subsequently, a total of 3648 trials have been concluded since that time."

Answered by AI

To what extent is enrollment being offered for this clinical trial?

"At this time, the trial is not actively recruiting. It was first posted on December 6th 2011 and last updated March 9th 2022; however, there are currently 1720 trials searching for participants with noncontiguous stage II mantle cell lymphoma and another 1705 trials that involve Ofatumumab presently looking for volunteers to enroll."

Answered by AI

Does this research trial accept participants below the age of 40?

"According to the criteria for this medical study, the minimum age of enrolment is 18 and the upper limit is 70."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025