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Alkylating agents

BEACOPP regimen for Lymphoma

Phase 3

Waitlist Available

Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from one week prior to randomization till 10 years after end of treatment or death

Awards & highlights

Study Summary

This trial will compare two different combination chemotherapy regimens to see which is more effective in treating patients with stage III or stage IV Hodgkin's lymphoma.

Eligible Conditions

Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from one week prior to randomization till 10 years after end of treatment or death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from one week prior to randomization till 10 years after end of treatment or death

This trial's timeline: 3 weeks for screening, Varies for treatment, and from one week prior to randomization till 10 years after end of treatment or death for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Event-free survival

Secondary outcome measures

Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma

Disease-free survival in patients with complete response

Overall survival

+1 more

Side effects data

From 2022 Phase 2 trial • 371 Patients • NCT00822120

74%

Neutrophils/granulocytes (ANC/AGC)

63%

Leukocytes (total WBC)

60%

Nausea

60%

Fatigue (asthenia, lethargy, malaise)

51%

Hemoglobin

34%

Constipation

25%

Neuropathy: sensory

24%

Lymphopenia

24%

Hair loss/Alopecia (scalp or body)

21%

Glucose, serum-high (hyperglycemia)

20%

Vomiting

20%

ALT, SGPT (serum glutamic pyruvic transaminase)

17%

Dyspnea (shortness of breath)

16%

AST, SGOT

14%

Pain - Head/headache

13%

Anorexia

13%

Insomnia

13%

Cough

12%

Pain - Muscle

12%

Rash/desquamation

11%

Alkaline phosphatase

11%

Mucositis/stomatitis (clinical exam) - Oral cavity

11%

Albumin, serum-low (hypoalbuminemia)

11%

Taste alteration (dysgeusia)

10%

Pain - Abdomen NOS

10%

Diarrhea

Sweating (diaphoresis)

Dizziness

Calcium, serum-low (hypocalcemia)

Pain - Joint

Mucositis/stomatitis (functional/symp) - Oral cav

Heartburn/dyspepsia

Pain - Back

Fever in absence of neutropenia, ANC lt1.0x10e9/L

Pain-Other

Sodium, serum-low (hyponatremia)

Rigors/chills

Platelets

Pain - Bone

Pain - Throat/pharynx/larynx

Pruritus/itching

Mood alteration - anxiety

Pain - Chest/thorax NOS

Weight gain

Pain - Extremity-limb

Potassium, serum-low (hypokalemia)

Creatinine

Dermatology/Skin-Other

Pain - Oral cavity

Edema: limb

Allergic rhinitis

Ocular/Visual-Other

Hyperpigmentation

Metabolic/Laboratory-Other

Nail changes

Weight loss

Neuropathy: motor

Mood alteration - depression

Pain - Chest wall

Rash: acne/acneiform

Infection-Other

Dehydration

SVT and nodal arrhythmia - Sinus tachycardia

Hot flashes/flushes

Thrombosis/thrombus/embolism

Hypotension

Febrile neutropenia

Glucose, serum-low (hypoglycemia)

Potassium, serum-high (hyperkalemia)

Allergic reaction/hypersensitivity

Flatulence

Bilirubin (hyperbilirubinemia)

Dysphagia (difficulty swallowing)

Hemorrhage, pulmonary/upper respiratory - Nose

Bruising (in absence of Gr 3-4 thrombocytopenia)

Cytokine release syndrome/acute infusion reaction

Pneumonitis/pulmonary infiltrates

Hypertension

Phlebitis (including superficial thrombosis)

Palpitations

PTT (Partial thromboplastin time)

Gastritis (including bile reflux gastritis)

Muscle weakness, not d/t neuropathy - body/general

Magnesium, serum-low (hypomagnesemia)

Phosphate, serum-low (hypophosphatemia)

Hemorrhage, GU - Urinary NOS

Urinary frequency/urgency

Pulmonary/Upper Respiratory-Other

Voice changes/dysarthria

100%

80%

60%

40%

20%

Study treatment Arm

HIV-negative: Initial ABVD

HIV-negative and PET-positive: BEACOPP Escalated

HIV-positive: Initial ABVD

HIV-positive and PET-negative: Continued ABVD

HIV-negative and PET-negative: Continued ABVD

HIV-positive and PET-positive: BEACOPP Standard

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BEACOPPExperimental Treatment10 Interventions

4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline

Group II: ABVDActive Control5 Interventions

8 cycles of ABVD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgrastim

FDA approved

Prednisone

FDA approved

Cyclophosphamide

FDA approved

Procarbazine

FDA approved

Bleomycin

FDA approved

Pegfilgrastim

FDA approved

Doxorubicin

FDA approved

Vincristine

FDA approved

Etoposide

FDA approved

Vincristine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nordic Lymphoma GroupNETWORK

17 Previous Clinical Trials

3,154 Total Patients Enrolled

15 Trials studying Lymphoma

2,926 Patients Enrolled for Lymphoma

Lymphoma Trials OfficeOTHER

9 Previous Clinical Trials

2,944 Total Patients Enrolled

8 Trials studying Lymphoma

2,744 Patients Enrolled for Lymphoma

NCIC Clinical Trials GroupNETWORK

189 Previous Clinical Trials

144,289 Total Patients Enrolled

16 Trials studying Lymphoma

3,415 Patients Enrolled for Lymphoma

Frequently Asked Questions

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

Will this test be available to patients who are over 55 years old?

"As long as they are between the ages of 16 and 60, patients meet the age requirements for this clinical trial."

Answered by AI

For what types of patients is this trial most seeking?

"This study is looking for 552 lymphoma patients that meet the following age, performance, and prognosis criteria: 16 to 60 years old, WHO Performance status of 0-2, and a life expectancy of more than 3 months. Additionally, the participants must have at least one target lesion that can be measured and must not have lymphocyte predominant, nodular type lymphoma."

Answered by AI

What conditions does the BEACOPP regimen usually treat?

"BEACOPP is a course of treatment that can be used to combat merkel cell cancer. Other conditions that BEACOPP can improve include squamous cell carcinoma, leukemia, and ophthalmia, sympathetic."

Answered by AI

Are there other research projects that have used the BEACOPP approach?

"As of now, there are 311 Phase 3 trials and 1458 active studies investigating BEACOPP regimen in general. Most of these trials are based in Bethesda, Maryland, but there are 52368 locations conducting clinical trials for BEACOPP regimen."

Answered by AI

Is this a groundbreaking new clinical trial?

"As of now, there are 1458 active trials for BEACOPP regimen being conducted in 2922 different cities, spanning 79 countries. The first trial of this sort began in 1997. Alfacell Corporation sponsored the study, which had 300 participants and completed its Phase 3 drug approval stage. In the 24 years since the initial BEACOPP study, 2479 similar studies have been completed."

Answered by AI

Has the BEACOPP regimen gone through the FDA's approval process?

"There is some existing data that BEACOPP is effective and multiple rounds of data that support its safety, so it received a score of 3."

Answered by AI

Are there still places available in this trial for new patients?

"The clinicaltrials.gov website indicates that this study is no longer recruiting patients. The study was originally posted on August 1st, 2002 and was last updated on February 11th, 2021. There are, however, 3216 other trials currently looking for participants."

Answered by AI

Is this clinical trial taking place at a great number of locations across America?

"There are 22 hospitals and clinics running this clinical trial, including CancerCare Manitoba in Winnipeg, Edmond Odette Cancer Centre at Sunnybrook in Toronto, and Doctor H. Bliss Murphy Cancer Centre in St. Johns."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Eight Cycles of ABVD Versus Four Cycles of Beacopp<sub>escalated</sub> Plus Four Cycles of Beacopp<sub>baseline</sub> in Stage III to IV, International Prognostic Score ≥ 3, High-risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial

Carde, Patrice, Matthias Karrasch, Catherine Fortpied, Pauline Brice, Hussein Khaled, Olivier Casasnovas, Denis Caillot, et al.. 2016. “Eight Cycles of ABVD Versus Four Cycles of Beacoppescalated Plus Four Cycles of Beacoppbaseline in Stage III to IV, International Prognostic Score ≥ 3, High-risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.5648.

clinicaltrials.govStudy

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

2002. "Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00049595.