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Chemotherapy

EPOCH + Rituximab for 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

Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min

All stages (I-IV) of disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the participants were followed for a median of 15.4 years.

Awards & highlights

Study Summary

This trial is testing whether reducing the amount of chemotherapy given to HIV-infected patients with non-Hodgkin's lymphoma will help rid the body of the lymphoma while decreasing the risk of infections and future cancers.

Who is the study for?

This trial is for adults over 18 with non-Hodgkin's lymphoma and HIV, who haven't had certain chemotherapies or rituximab. They should be relatively healthy otherwise, with adequate organ function and no severe heart issues, untreated CNS infections, or AIDS-related wasting.Check my eligibility

What is being tested?

The study tests a chemotherapy combo called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) in cycles to see if it can treat lymphoma effectively while minimizing immune system damage. Patients are monitored via blood tests and scans.See study design

What are the potential side effects?

EPOCH-R treatment may cause side effects like lowered blood cell counts increasing infection risk; nausea; hair loss; fatigue; potential heart problems due to doxorubicin; nerve damage from vincristine; and possible allergic reactions to rituximab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or only slightly reduced.

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My condition is at any stage from early to advanced.

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I am 18 years old or older.

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I can perform daily activities, but my health limits me to varying degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the participants were followed for a median of 15.4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the participants were followed for a median of 15.4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the participants were followed for a median of 15.4 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

Median Progression Free Survival (PFS)

Progression Free Survival at 1 Year

Secondary outcome measures

1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)

1 Year Overall Survival

Median Duration of Complete Response/Complete Response Unconfirmed

+10 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)

Side effects data

From 2021 Phase 2 trial • 31 Patients • NCT00069238

97%

BLOOD/BONE MARROW:: Leukocytes (total white blood count (WBC))

97%

BLOOD/BONE MARROW:: Lymphopenia

97%

BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)

94%

BLOOD/BONE MARROW:: Hemoglobin

90%

BLOOD/BONE MARROW:: Platelets

77%

NEUROLOGY:: Neuropathy: sensory

65%

GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Oral cavity

65%

METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)

61%

METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)

58%

CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)

58%

GASTROINTESTINAL:: Nausea

58%

METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)

55%

METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)

55%

METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)

52%

DEATH:: Death due to progression

52%

INFECTION:: Febrile neutropenia

52%

METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)

52%

METABOLIC/LABORATORY:: Alkaline phosphatase

52%

METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)

48%

DERMATOLOGY/SKIN:: Hair loss/alopecia (scalp or body)

48%

METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)

45%

GASTROINTESTINAL:: Diarrhea

45%

METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)

45%

METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)

42%

GASTROINTESTINAL:: Vomiting

42%

PAIN:: Pain:: Head/headache

39%

GASTROINTESTINAL:: Constipation

39%

PAIN:: Pain:: Bone

35%

CONSTITUTIONAL SYMPTOMS

35%

GASTROINTESTINAL:: Anorexia

32%

METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)

32%

PAIN:: Pain:: Muscle

29%

CONSTITUTIONAL SYMPTOMS:: Rigors/chills

29%

NEUROLOGY:: Dizziness

29%

ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

29%

CARDIAC GENERAL:: Hypotension

29%

DERMATOLOGY/SKIN:: Rash/desquamation

29%

METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)

23%

ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)

23%

CONSTITUTIONAL SYMPTOMS:: Weight loss

23%

GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity

23%

DEATH:: Death related to the study

23%

PAIN:: Pain:: Abdomen Not otherwise specified (NOS)

23%

PAIN:: Pain:: Back

23%

PULMONARY/UPPER RESPIRATORY:: Cough

19%

PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)

19%

METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)

19%

RENAL/GENITOURINARY:: Cystitis

16%

RENAL/GENITOURINARY:: Urinary frequency/urgency

16%

CONSTITUTIONAL SYMPTOMS:: Insomnia

16%

DERMATOLOGY/SKIN:: Nail changes

16%

METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)

16%

PAIN:: Pain:: Joint

16%

VASCULAR:: Thrombosis/thrombus/embolism

16%

PAIN:: Pain:: Chest/thorax NOS

13%

COAGULATION:: PTT (Partial Thromboplastin Time)

13%

CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)

13%

GASTROINTESTINAL:: Heartburn/dyspepsia

13%

GASTROINTESTINAL:: Taste alteration (dysgeusia)

13%

HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose

13%

INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS

13%

BLOOD/BONE MARROW:: Bone marrow cellularity

13%

LYMPHATICS:: Edema: limb

13%

METABOLIC/LABORATORY:: Bicarbonate, serum-low

13%

METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)

10%

NEUROLOGY:: Confusion

10%

NEUROLOGY:: Mood alteration:: Anxiety

10%

NEUROLOGY:: Neuropathy: motor

10%

DERMATOLOGY/SKIN:: Pruritus/itching

10%

METABOLIC/LABORATORY:: Creatinine

10%

OCULAR/VISUAL:: Vision-blurred vision

10%

VASCULAR:: Thrombosis/embolism (vascular access-related)

NEUROLOGY:: Syncope (fainting)

CARDIAC ARRHYTHMIA:: Palpitations

CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular tachycardia

DERMATOLOGY/SKIN:: Hyperpigmentation

GASTROINTESTINAL:: Dry mouth/salivary gland (xerostomia)

INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils

GASTROINTESTINAL:: Flatulence

HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI NOS

METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)

PAIN:: Pain:: Eye

PULMONARY/UPPER RESPIRATORY:: Hypoxia

PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)

NEUROLOGY:: Tremor

NEUROLOGY:: Mood alteration:: Depression

MUSCULOSKELETAL/SOFT TISSUE:: Musculoskeletal/Soft Tissue - Other (Specify, __)

NEUROLOGY:: Somnolence/depressed level of consciousness

NEUROLOGY:: Mood alteration:: Agitation

DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)

DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Specify, excoriation)

DERMATOLOGY/SKIN:: Dry skin

GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Pharynx

LYMPHATICS:: Edema: trunk/genital

NEUROLOGY:: Laryngeal nerve dysfunction

HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI Not otherwise specified (NOS)

INFECTION:: Infection

INFECTION:: Infection (documented clinically or microbiologically)

INFECTION:: Infection with unknown ANC:: Blood

AUDITORY/EAR:: Otitis, middle ear (non-infectious)

CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular arrhythmia NOS

CARDIAC ARRHYTHMIA:: Vasovagal episode

CARDIAC GENERAL:: Hypertension

DERMATOLOGY/SKIN:: Flushing

DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes

DERMATOLOGY/SKIN:: Skin breakdown/decubitus ulcer

GASTROINTESTINAL:: Dehydration

GASTROINTESTINAL:: Dental: teeth

GASTROINTESTINAL:: Gastritis (including bile reflux gastritis)

GASTROINTESTINAL:: Gastrointestinal - Other (Specify, duodenitis)

GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Esophagus

GASTROINTESTINAL:: Proctitis

GASTROINTESTINAL:: Typhlitis (cecal inflammation)

HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Specify, R. neck after picc line)

HEMORRHAGE/BLEEDING:: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)

INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Blood

INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Oral cavity-gums (gingivitis)

INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus

INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Skin (cellulitis)

INFECTION:: Infection with unknown ANC:: Urinary tract NOS

MUSCULOSKELETAL/SOFT TISSUE:: Arthritis (non-septic)

MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area (not due to neuropathy)

MUSCULOSKELETAL/SOFT TISSUE:: Soft tissue necrosis:: Extremity-lower

OCULAR/VISUAL:: Ocular/Visual - Other (Specify, red eyes)

OCULAR/VISUAL:: Ophthalmoplegia/diplopia (double vision)

PAIN:: Pain:: Extremity-limb

PAIN:: Pain:: Throat/pharynx/larynx

VASCULAR:: Phlebitis (including superficial thrombosis)

GASTROINTESTINAL:: Gastrointestinal - Other (Specify, tongue-blue spot)

PAIN:: Pain - Other (Specify, Pain: jaw pain)

PAIN:: Pain - Other (Specify, Pain:teeth)

PAIN:: Pain - Other (Specify, Pain: tooth

HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Oral cavity

AUDITORY/EAR:: Tinnitus

CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia

CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia

GASTROINTESTINAL:: Esophagitis

GASTROINTESTINAL:: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)

HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS

HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder

HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS

HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Bronchopulmonary NOS

INFECTION:: Infection - Other (Specify, BLOOD)

INFECTION:: Infection with unknown ANC:: Oral cavity-gums (gingivitis)

LYMPHATICS:: Edema: head and neck

METABOLIC/LABORATORY:: Amylase

MUSCULOSKELETAL/SOFT TISSUE:: Joint-effusion

OCULAR/VISUAL:: Vision-photophobia

OCULAR/VISUAL:: Watery eye (epiphora, tearing)

PAIN:: Pain - Other (Specify, L wrist)

PAIN:: Pain:: Bladder

PAIN:: Pain:: Buttock

PAIN:: Pain:: Dental/teeth/peridontal

PAIN:: Pain:: Neck

PAIN:: Pain:: Rectum

PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing

PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions

PULMONARY/UPPER RESPIRATORY:: Pneumonitis/pulmonary infiltrates

RENAL/GENITOURINARY:: Incontinence, urinary

RENAL/GENITOURINARY:: Obstruction, GU:: Ureter

OCULAR/VISUAL:: Ocular/Visual - Other (Specify, dilated, non-reactive R.pupil

PAIN:: Pain - Other (Specify, lumbar puncture (LP) site)

PAIN:: Pain - Other (Specify, Pain L big toe

PAIN:: Pain - Other (Specify, Pain:groin)

INFECTION:: Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils

INFECTION:Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils

100%

80%

60%

40%

20%

Study treatment Arm

All Participants

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1-Combination Chemo and Biological TherapyExperimental Treatment3 Interventions

Combination chemo and biological therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Filgrastim

FDA approved

EPOCH

2003

Completed Phase 2

~180

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,085 Total Patients Enrolled

1,381 Trials studying Lymphoma

382,332 Patients Enrolled for Lymphoma

Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)

18 Previous Clinical Trials

2,104 Total Patients Enrolled

14 Trials studying Lymphoma

1,756 Patients Enrolled for Lymphoma

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00006436 — Phase 2

Lymphoma Research Study Groups: Arm 1-Combination Chemo and Biological Therapy

Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00006436 — Phase 2

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006436 — Phase 2

Frequently Asked Questions

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

How many participants are allowed for this research study?

"This clinical trial is no longer accepting participants; the study was originally posted on January 29th 2001 and last updated on July 21st 2022. For those looking for other studies related to lymphoma, large b-cell, diffuse there are currently 1750 trials available while 541 trials are actively recruiting patients with EPOCH regimens."

Answered by AI

What medical conditions are usually treated with EPOCH?

"Diffuse Large B-cell Lymphoma (DLBCL) is commonly treated with a combination of EPOCH. This medication has also been successful in managing mobilization for Hematopoietic Stem Cell Therapy, other types of B-Cell lymphomas, and Polyangium."

Answered by AI

What is the goal of this medical research initiative?

"The primary goal of this medical research is to determine Median Progression Free Survival (PFS). Secondary objectives include assessing the safety and toxicity of SC-EPOCH-R, the number and types of adverse events experienced by participants, as well as responses to antiretroviral therapy. Toxicity will be measured using Common Toxicity Criteria v2.0 while febrile neutropenia, a life-threatening complication requiring urgent hospitalization and antibiotics, will also be monitored over a time frame that assesses progressive disease."

Answered by AI

Are there any vacancies for participants in this trial?

"Data from clinicaltrials.gov conveys that this particular medical trial is not actively recruiting. The study was first posted on Jan 29th 2001 and the last update occurred on July 21st 2022. 2,291 other trials remain open for enrolment in contrast to this one, however."

Answered by AI

What adverse effects might the EPOCH regimen pose to those undergoing treatment?

"Due to the lack of data confirming efficacy, our team assigned EPOCH a safety rating of 2 on a scale from 1-3. However, there is evidence that this drug may be safe for use in humans."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Circulating Tumor DNA Measurements as Early Outcome Predictors in Diffuse Large B-cell Lymphoma

Kurtz, David M., Florian Scherer, Michael C. Jin, Joanne Soo, Alexander F.M. Craig, Mohammad Shahrokh Esfahani, Jacob J. Chabon, et al.. 2018. “Circulating Tumor DNA Measurements as Early Outcome Predictors in Diffuse Large B-cell Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.78.5246.

New England Journal of MedicineJournal

Low-intensity Therapy in Adults with Burkitt's Lymphoma

Dunleavy, Kieron, Stefania Pittaluga, Margaret Shovlin, Seth M. Steinberg, Diane Cole, Cliona Grant, Brigitte Widemann, et al.. 2013. “Low-intensity Therapy in Adults with Burkitt's Lymphoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1308392.

clinicaltrials.govStudy

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

Mark Roschewski, M.D. 2001. "EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00006436.

All > Diffuse Large B Cell Lymphoma