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Alkylating agents

Ofatumumab for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Inhye Ahn, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
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 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of ofatumumab when given with fludarabine and, in some cases, cyclophosphamide in treating patients with CLL or SLL.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Progression Free Survival Rate 2 Years After Initiation of Induction Therapy
Secondary outcome measures
Median Relationship of CD20 Expression With MRD Negativity Rate
Number of Grade 3 and 4 Treatment Related Adverse Events
Participants Overall Response Rates Following Induction Chemoimmunotherapy.
+4 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%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
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%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Proctitis
1%
Pneumonia staphylococcal
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: FO Arm (fludarabine and ofatumumab)Experimental Treatment2 Interventions
For patients with non-high risk FISH changes
Group II: FCO Arm (fludarabine, cyclophosphamide, and ofatumumab)Experimental Treatment3 Interventions
For patients with high risk FISH changes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1470
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

University of VirginiaOTHER
753 Previous Clinical Trials
1,244,999 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,420 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,833 Previous Clinical Trials
47,306,464 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01145209 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: FCO Arm (fludarabine, cyclophosphamide, and ofatumumab), FO Arm (fludarabine and ofatumumab)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01145209 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01145209 — Phase 2

Frequently Asked Questions

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

Can individuals still join in on this medical study?

"At present, recruitment for this clinical trial has ended. This medical study was initially posted on July 1st 2010 and last updated October 13th 2022. For those searching for similar studies with Small Lymphocytic Lymphoma, there are currently 2862 trials in progress; additionally, 908 Ofatumumab trials remain open to participants."

Answered by AI

Is the cutoff for study participants restricted to those under 20 years of age?

"This study requires patients to be between 18 and 99 years old. For those under the age of 18, there are 932 studies; for those over 65, 3154 separate clinical trials exist."

Answered by AI

What is the maximum capacity of participants for this research endeavor?

"At the present moment, this study has ceased its recruitment efforts. Initially posted in July of 2010 and last updated on October 13th 2022, individuals interested in clinical trials should instead direct their attention to 2862 other studies involving small lymphocytic lymphoma or 908 trials with Ofatumumab enrolment options."

Answered by AI

Could you provide an overview of the prior experiments conducted with Ofatumumab?

"Currently, there are 908 clinical trials researching Ofatumumab. Out of those studies, 167 have reached Phase 3 status. Philadelphia, Pennsylvania is the epicentre for much of this research; however, 29187 trial sites exist across the globe that are looking into its efficacy."

Answered by AI

Is enrollment open for this research endeavor?

"This clinical trial seeks 32 participants with small lymphocytic lymphoma, ranging in age from 18 to 99. Eligibility relies on the following conditions: having a B-lymphocyte count greater than 5000 cells/micro L (or less if accompanied by histologically confirmed lymph node involvement), experiencing weight loss of 10% or more within 6 months, displaying large blood lymhocytes that are equal to 55% or lower, exhibiting extreme fatigue and night sweats for over one month without evidence of infection, and enduring fever at 100.5 degrees Fahrenheit or higher lasting two weeks or longer but not linked to an infectious agent."

Answered by AI

Has Ofatumumab been granted authorization by the FDA?

"Our experts at Power assigned Ofatumumab a score of 2, signifying that there is only limited evidence regarding the safety of this medication as it has yet to progress past Phase 2 trials."

Answered by AI

How is ofatumumab commonly utilized to benefit patients?

"Ofatumumab is the prescribed medication for treating lung cancer, but it may also be of benefit to patients with acute myelocytic leukemia, multiple sclerosis and retinoblastoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL
2010. "Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01145209.
~2 spots leftby Apr 2025
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