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Alkylating agents

Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma

Phase 2
Waitlist Available
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 time of progression or death at 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a chemotherapy regimen called DA-EPOCH-R, which includes six different drugs. It targets adults with Burkitt lymphoma and certain types of aggressive lymphomas. The goal is to treat these cancers effectively while reducing side effects. The drugs work together to kill cancer cells and prevent them from growing. DA-EPOCH-R includes etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and rituximab.

Eligible Conditions
  • Burkitt Lymphoma
  • Plasmablastic Lymphoma
  • Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
Secondary study objectives
Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
Other study objectives
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2023 Phase 2 trial • 194 Patients • NCT01092182
65%
Anemia
64%
White blood cell decreased
60%
Neutrophil count decreased
60%
Lymphocyte count decreased
53%
Platelet count decreased
27%
Constipation
27%
Fatigue
27%
Febrile neutropenia
27%
Peripheral sensory neuropathy
25%
Mucositis oral
25%
Hypophosphatemia
22%
Hypokalemia
21%
Diarrhea
21%
Hypocalcemia
19%
Hypoalbuminemia
19%
Hyperglycemia
15%
Alkaline phosphatase increased
14%
Headache
14%
Edema limbs
14%
Nausea
11%
Death NOS
10%
Urinary tract infection
10%
Fever
10%
Hypernatremia
10%
Peripheral motor neuropathy
9%
Dyspnea
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Back pain
9%
Bone pain
9%
Vomiting
7%
Anorexia
7%
Pain
7%
Alopecia
7%
Hypertension
7%
Hypomagnesemia
7%
Hyponatremia
7%
Hypotension
7%
Insomnia
6%
Generalized muscle weakness
6%
Abdominal pain
6%
Blood bilirubin increased
6%
Dysgeusia
6%
Thromboembolic event
6%
Weight loss
5%
Sepsis
5%
Enterocolitis infectious
5%
Syncope
5%
Mucosal infection
5%
Sinus tachycardia
4%
Acute kidney injury
4%
Lymphocyte count increased
4%
Dizziness
4%
Hypoglycemia
4%
Respiratory failure
4%
Aspiration
4%
Dyspepsia
4%
Hypercalcemia
4%
Hyperkalemia
4%
Hypermagnesemia
4%
Ileus
4%
Infusion related reaction
4%
Pain in extremity
4%
Paresthesia
4%
Rash acneiform
2%
Nervous system disorders - Other, numbness in left arm
2%
Activated partial thromboplastin time prolonged
2%
Allergic reaction
2%
Muscle weakness trunk
2%
Gastroesophageal reflux disease
2%
Urinary frequency
2%
Ear pain
2%
Anxiety
2%
Confusion
2%
Hyperuricemia
2%
Dehydration
2%
Flatulence
2%
Multi-organ failure
2%
Gastritis
2%
Allergic rhinitis
2%
Atrial fibrillation
2%
Blurred vision
2%
Chills
2%
Dry mouth
2%
Dysphagia
2%
Hypoxia
2%
Leukocytosis
2%
Pleural effusion
2%
Presyncope
2%
Productive cough
2%
Urinary tract pain
2%
Urticaria
2%
Watering eyes
2%
Blood and lymphatic system disorders - Other, T bili
2%
Flu like symptoms
1%
Delusions
1%
Delirium
1%
Pancreatic enzymes decreased
1%
Cardiac troponin I increased
1%
Tumor lysis syndrome
1%
Eye infection
1%
Neck pain
1%
Photophobia
1%
Colitis
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Acute coronary syndrome
1%
Stomach pain
1%
Depression
1%
Sore throat
1%
Infections and infestations - Other, CMV reactivation
1%
Tracheal fistula
1%
Pancreatitis
1%
Scrotal pain
1%
Infections and infestations - Other, bacteremia, Klebsiella infection
1%
Hemorrhoids
1%
Ejection fraction decreased
1%
Treatment related secondary malignancy
1%
Agitation
1%
Atrial flutter
1%
Cough
1%
Lung infection
1%
Memory impairment
1%
Palpitations
1%
Somnolence
1%
Toxic epidermal necrolysis
1%
Floaters
1%
Gastrointestinal disorders - Other, bleeding
1%
Ascites
1%
Flank pain
1%
GGT increased
1%
Hematoma
1%
Jejunal perforation
1%
Lower gastrointestinal hemorrhage
1%
Myocardial infarction
1%
Pneumonitis
1%
Proteinuria
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
1%
Anal fistula
1%
Anorectal infection
1%
Bladder infection
1%
Bronchial infection
1%
Bruising
1%
CD4 lymphocytes decreased
1%
Cardiac troponin T increased
1%
Catheter related infection
1%
Creatinine increased
1%
Esophageal hemorrhage
1%
Esophageal infection
1%
Fall
1%
Sinusitis
1%
Hepatic failure
1%
Hoarseness
1%
Investigations - Other, disease progression
1%
Joint effusion
1%
Laryngeal inflammation
1%
Lipase increased
1%
Myalgia
1%
Nasal congestion
1%
Oral pain
1%
Skin and subcutaneous tissue disorders - Other, abdominal abscess
1%
Peritoneal infection
1%
Pharyngeal mucositis
1%
Skin ulceration
1%
Postnasal drip
1%
Pruritus
1%
Pulmonary edema
1%
Rash maculo-papular
1%
Rash pustular
1%
Rectal hemorrhage
1%
Retinal detachment
1%
Tinnitus
1%
Weight gain
1%
Wound infection
1%
Blood and lymphatic system disorders - Other, thrombosis/embolism
1%
Infections and infestations - Other, infection
1%
Infections and infestations - Other, throat
1%
Infections and infestations - Other, VRE
1%
Infections and infestations - Other, blood, candida glabrata
1%
Infections and infestations - Other, oral thrush
1%
Musculoskeletal and connective tissue disorder - Other, shin pain with numbness
1%
Nervous system disorders - Other, neuropathy
1%
Skin and subcutaneous tissue disorders - Other, dermatitis
1%
Upper respiratory infection
1%
Urethral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
Group B - High-Risk Burkitt Lymphoma (BL)
Group A - Low-risk Burkitt Lymphoma (BL)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group C - DLBCL high risk armExperimental Treatment1 Intervention
Diffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Group II: Group B - Burkitt lymphoma High Risk ArmExperimental Treatment1 Intervention
Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Group III: Group A - Burkitt lymphoma Low Risk ArmExperimental Treatment1 Intervention
Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EPOCH-RR
2010
Completed Phase 2
~200
EPOCH-R
2000
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,022,976 Total Patients Enrolled
139 Trials studying Burkitt Lymphoma
14,518 Patients Enrolled for Burkitt Lymphoma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,317 Total Patients Enrolled
2 Trials studying Burkitt Lymphoma
356 Patients Enrolled for Burkitt Lymphoma
~12 spots leftby Dec 2025
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