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Alkylating agents

EPOCH + Rituximab for Non-Hodgkin's 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

Adequate major organ function: in adults - serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min, bilirubin less than 1.5 mg/dl, ANC greater than 1,000 and platelets greater than 100,000; in children - serum CR less than or equal to age-adjusted normal, bilirubin less than 1.5 mg/dl, ANC greater than 1,000 and platelets greater than 100,000 unless impairment is due to organ involvement by lymphoma or immune-mediated mechanism caused by lymphoma

Any stage for MGZL and PMBL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of progression

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat lymphoma. The goal is to reduce toxicity while still being effective.

Who is the study for?

This trial is for individuals aged 12 or older with various types of aggressive Non-Hodgkin's Lymphoma, including Burkitt and Diffuse Large B-Cell Lymphomas. Participants must have confirmed diagnoses but no prior systemic chemotherapy, except limited treatments for urgent issues. They need good organ function, not be pregnant or nursing, HIV negative, without serious heart conditions in the past year, and free from other cancers (except certain skin cancers) in the last five years.Check my eligibility

What is being tested?

The trial tests a combination chemotherapy called EPOCH (Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin) alongside Rituximab. This regimen aims to reduce blood-related side effects using Granulocyte Colony-Stimulating Factor support. It's designed for those who haven't had previous systemic treatments for their lymphoma.See study design

What are the potential side effects?

Potential side effects include blood disorders like low white cell counts increasing infection risk; nausea; hair loss; nerve damage causing numbness or tingling; mouth sores; fatigue; and potential heart problems due to Doxorubicin.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys, liver, and blood cells are functioning well.

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My condition is either MGZL or PMBL at any stage.

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My lymphoma is either mediastinal gray zone or primary mediastinal B cell type.

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I haven't had heart issues like a heart attack or heart failure in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initiation of study drug until 30 days after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initiation of study drug until 30 days after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study drug until 30 days after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response and PFS

Secondary outcome measures

Safety and Toxicity

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

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

NEUROLOGY:: Mood alteration:: Depression

NEUROLOGY:: Mood alteration:: Agitation

NEUROLOGY:: Somnolence/depressed level of consciousness

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 AExperimental Treatment2 Interventions

EPOCH + Rituximab every 3 weeks for 6 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EPOCH

2003

Completed Phase 2

~180

Rituximab

1999

Completed Phase 4

~1880

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,923,924 Total Patients Enrolled

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

18 Previous Clinical Trials

1,816 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00001337 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Arm A

Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00001337 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00001337 — Phase 2

Frequently Asked Questions

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

What have been the overall findings on EPOCH's safety profile?

"Our team at Power assessed the safety of EPOCH to be a score 2, as it is undergoing Phase 2 trials which has evidence for safety but not efficacy."

Answered by AI

Is recruitment ongoing for this research protocol?

"Unfortunately, this clinical trial is not presently open for recruitment. It was first posted on May 8th 1993 and last updated on November 4th 2022; however, if you are looking to register into a different study there are 1809 trials recruiting patients with Burkitt Lymphoma and 406 EPOCH related ones still admitting participants."

Answered by AI

How many participants is the research team looking to recruit?

"At this time, the trial is not recruiting any more participants. The clinical study was posted on 8 May 1993 and last revised on 4 November 2022. However, if you are looking for other trials to join, there are 1809 studies pertaining to Burkitt lymphoma that currently require patients as well as 406 EPOCH-related experiments requiring volunteers."

Answered by AI