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Alkylating agents

EPOCH-RR for Burkitt 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
63%
Anemia
56%
Neutrophil count decreased
55%
Lymphocyte count decreased
53%
Platelet count decreased
48%
White blood cell decreased
30%
Febrile neutropenia
27%
Peripheral sensory neuropathy
26%
Headache
23%
Mucositis oral
22%
Fatigue
22%
Hypophosphatemia
21%
Hypokalemia
20%
Constipation
18%
Diarrhea
18%
Hypoalbuminemia
18%
Nausea
17%
Hypocalcemia
16%
Hyperglycemia
15%
Alanine aminotransferase increased
14%
Hyponatremia
13%
Fever
13%
Aspartate aminotransferase increased
10%
Death NOS
10%
Insomnia
10%
Pain
9%
Alopecia
9%
Anorexia
9%
Blood bilirubin increased
9%
Bone pain
9%
Vomiting
8%
Dyspnea
8%
Urinary tract infection
8%
Mucosal infection
8%
Abdominal pain
8%
Hypotension
8%
Peripheral motor neuropathy
7%
Dizziness
7%
Alkaline phosphatase increased
7%
Back pain
7%
Dehydration
7%
Hypomagnesemia
6%
Sepsis
6%
Cough
6%
Thromboembolic event
5%
Atrial fibrillation
5%
Chills
5%
Hypertension
5%
Paresthesia
5%
Syncope
4%
Sore throat
4%
Tumor lysis syndrome
4%
Generalized muscle weakness
4%
Hypoglycemia
4%
Dysphagia
4%
Sinus tachycardia
4%
Skin and subcutaneous tissue disorders - Other, abdominal abscess
4%
Hypernatremia
3%
Depression
3%
Neck pain
3%
Hematoma
3%
Allergic reaction
3%
Hemorrhoids
3%
Confusion
3%
Lung infection
3%
Abdominal distension
3%
Blurred vision
3%
Edema limbs
3%
Hiccups
3%
Hyperkalemia
3%
Leukocytosis
3%
Pruritus
3%
Weight gain
2%
Hematuria
2%
Enterocolitis infectious
2%
Memory impairment
2%
Toothache
2%
Intracranial hemorrhage
2%
Gastroesophageal reflux disease
2%
Sinus bradycardia
2%
Enterocolitis
2%
Agitation
2%
Non-cardiac chest pain
2%
Gastrointestinal disorders - Other, bleeding
2%
Colitis
2%
Hypoxia
2%
Lower gastrointestinal hemorrhage
2%
Vascular access complication
2%
Abdominal infection
2%
Cerebrospinal fluid leakage
2%
Dyspepsia
2%
Esophagitis
2%
Fall
2%
Hoarseness
2%
Hypermagnesemia
2%
Infusion related reaction
2%
Laryngeal mucositis
2%
Nail loss
2%
Neck edema
2%
Pain in extremity
2%
Papulopustular rash
2%
Skin hyperpigmentation
2%
Skin infection
2%
Presyncope
2%
Superficial thrombophlebitis
2%
Tremor
2%
Weight loss
2%
Blood and lymphatic system disorders - Other, leukopenia
2%
Blood and lymphatic system disorders - Other, low platelet count
2%
General disorders and administration site conditions - Other, cerebellar infarct
2%
Typhlitis
1%
Infections and infestations - Other, clostridium difficile
1%
Delirium
1%
Gait disturbance
1%
Acute kidney injury
1%
Chest pain - cardiac
1%
Cardiac disorders - Other, 23% decreased EF
1%
Depressed level of consciousness
1%
Infections and infestations - Other, Infected Cholecystostomy tube in setting of neutropenia?
1%
Infections and infestations - Other, neutropenic fever
1%
Infections and infestations - Other, VRE-blood stream
1%
Dysphasia
1%
Bronchopulmonary hemorrhage
1%
Infections and infestations - Other, Blood
1%
Cardiac arrest
1%
Alkalosis
1%
Restrictive cardiomyopathy
1%
Infections and infestations - Other, cellulitis
1%
Sinusitis
1%
Elevated bilirubin
1%
Infections and infestations - Other, candida oral infection
1%
Infections and infestations - Other, thrush
1%
Infections and infestations - Other, encephalitis, persistent
1%
Pneumonitis
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
General disorders and administration site conditions - Other, sacral pressure ulcer
1%
Ejection fraction decreased
1%
Infections and infestations - Other, MRSA
1%
Lymphocyte count increased
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Infections and infestations - Other, influenza A/H1N1
1%
Adrenal insufficiency
1%
Arthralgia
1%
Creatinine increased
1%
Epistaxis
1%
Metabolism and nutrition disorders - Other, elevated LDH
1%
Infections and infestations - Other, gastrointestinal tract
1%
Small intestinal obstruction
1%
Cardiac disorders - Other, hypotension
1%
Device related infection
1%
Gastric perforation
1%
Hallucinations
1%
Infections and infestations - Other, parasitic infection
1%
Infections and infestations - Other, PICC line infection
1%
Rhinitis infective
1%
Allergic rhinitis
1%
Anxiety
1%
General disorders and administration site conditions - Other, specify
1%
General disorders and administration site conditions - Other, thalmic infarct
1%
Movements involuntary
1%
Infections and infestations - Other, oral cavity
1%
Hyperuricemia
1%
Muscle weakness lower limb
1%
Fecal incontinence
1%
Aspiration
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral pain
1%
Phlebitis infective
1%
Renal and urinary disorders - Other, acute kidney injury
1%
Respiratory failure
1%
Gastritis
1%
Vasovagal reaction
1%
Gastrointestinal disorders - Other, heme positive stool
1%
Gastrointestinal disorders - Other, odynohagia
1%
Infections and infestations - Other, liver infection
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
1%
Anorectal infection
1%
Bloating
1%
Blood and lymphatic system disorders - Other, DVT
1%
Chest wall pain
1%
Cognitive disturbance
1%
Dry skin
1%
Dysgeusia
1%
Elevated LFT's
1%
Eyelid function disorder
1%
Facial nerve disorder
1%
Glucose intolerance
1%
Hot flashes
1%
Hypercalcemia
1%
Hyperhidrosis
1%
Hypertriglyceridemia
1%
Ileus
1%
Nail discoloration
1%
Pain of skin
1%
Personality change
1%
Pharyngeal mucositis
1%
Pharyngolaryngeal pain
1%
Sleep apnea
1%
Pleural effusion
1%
Psychiatric disorders - Other, non verbal
1%
Rectal hemorrhage
1%
Renal and urinary disorders - Other, dysuria
1%
Seizure
1%
Supraventricular tachycardia
1%
Tinnitus
1%
Urinary tract pain
1%
Urinary urgency
1%
Urine output decreased
1%
Vertigo
1%
Wound infection
1%
Blood and lymphatic system disorders - Other, low ANC
1%
Infections and infestations - Other, blood infection
1%
Infections and infestations - Other, blood, E. coli
1%
Infections and infestations - Other, infection-oral
1%
Infections and infestations - Other, L posterior lung
1%
Infections and infestations - Other, left orbital cellulitis
1%
Infections and infestations - Other, polymicrobial bacteremia
1%
Infections and infestations - Other, herpes simplex oral ulcer
1%
Infections and infestations - Other, oral thrush
1%
Investigations - Other, heartburn
1%
Investigations - Other, night sweats
1%
Investigations - Other, fluid overload
1%
Metabolism and nutrition disorders - Other, malnutrition
1%
Skin and subcutaneous tissue disorders - Other, blister ball of R foot
1%
Skin and subcutaneous tissue disorders - Other, forehead itching
1%
Skin and subcutaneous tissue disorders - Other, pressure ulcer
1%
Skin and subcutaneous tissue disorders - Other, scalp wound
1%
Gastrointestinal disorders - Other, epigastric pain
1%
Flu like symptoms
1%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group B - High-Risk Burkitt Lymphoma (BL)
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)
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
13,920 Previous Clinical Trials
41,016,740 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 Nov 2025
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