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Alkylating agents
Ofatumumab for Acute Lymphoblastic Leukemia
Phase 2
Waitlist Available
Led By Elias Jabbour, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs including etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, with ofatumumab or rituximab, to see how well they work in treating patients with Burkitt lymphoma or acute lymphoblastic leukemia.
Eligible Conditions
- Refractory Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia
- Burkitt Lymphoma
- Burkitt/Burkitt-Like Lymphoma
- Lymphoma
- B-Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 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 rates
Secondary outcome measures
Complete response duration
Event-free survival
Incidence of adverse events
+1 moreSide 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%
Toxic skin eruption
3%
Renal failure acute
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%
Pneumonia staphylococcal
1%
Urinary tract infection
1%
Pneumonia aspiration
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
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
1Treatment groups
Experimental Treatment
Group I: Treatment (DA-EPOCH and ofatumumab or rituximab)Experimental Treatment7 Interventions
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Cyclophosphamide
1995
Completed Phase 3
~3770
Etoposide
2010
Completed Phase 3
~2440
Prednisone
2014
Completed Phase 4
~2370
Ofatumumab
2013
Completed Phase 3
~1470
Vincristine Sulfate
2005
Completed Phase 3
~10110
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,315 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,875 Total Patients Enrolled
Elias Jabbour, MDPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,224 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted into this research project?
"The clinicaltrial.gov website indicates that this study is not currently recruiting patients, with the most recent update having been on May 3rd, 2022. Although this particular trial isn't looking for new participants, there are 5585 other trials which are actively enrolling candidates."
Answered by AI
For what sorts of medical conditions is Ofatumumab regularly prescribed?
"While ofatumumab is most often used as a prostate cancer treatment, it can also help patients with pheochromocytomas, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Has Ofatumumab been given the green light by the FDA?
"While there is some data supporting ofatumumab's safety, it has not been proven effective yet and thus received a score of 2."
Answered by AI
How many people are currently signed up for this trial?
"Unfortunately, this particular study is no longer looking for new participants. It was originally posted on 1/14/2015 but the most recent edit was on 5/3/2022. If you are interested in other trials, there are currently 3851 clinical trials actively recruiting patients with leukemia, lymphocytic, acute, l1 and 1734 studies for Ofatumumab admitting new participants."
Answered by AI
What is the research history of Ofatumumab?
"As of the current moment, there are 1734 active clinical trials for Ofatumumab globally. Out of those, 386 have reached Phase 3. The majority of research sites for this medication are based in Ascoli Piceno, Provincia; however, there are a total 63313 locations running trials related to Ofatumumab."
Answered by AI
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