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Alkylating agents

Chemotherapy + Radiotherapy for Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Matthew Ehrhardt, MD, MS

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Low-Risk: IA, IIA (excluding patients with 'E' lesions or mediastinal bulk)

Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

Awards & highlights

Study Summary

This trial is using different chemotherapy regimens for low, intermediate, and high risk classical Hodgkin lymphoma patients. Two cycles of therapy will be given, and if there is no adequate response, radiotherapy will be given.

Who is the study for?

This trial is for children and young adults up to age 25 with untreated CD30+ classical Hodgkin lymphoma. Eligible participants have various stages of the disease, adequate organ function, and no prior therapy for Hodgkin's except limited emergency treatments. They must be able to perform normal activities without significant breathing issues.Check my eligibility

What is being tested?

The study tests different chemotherapy combinations based on risk levels: low/intermediate-risk patients receive BEABOVP regimen; high-risk patients get AEPA and CAPDac regimens. Some may also need radiotherapy if their nodes don't respond well after two cycles of chemo.See study design

What are the potential side effects?

Potential side effects include reactions to medication infusions, blood cell count changes leading to increased infection risk or bleeding problems, nausea, vomiting, hair loss from chemotherapy drugs like doxorubicin and cyclophosphamide, nerve damage from brentuximab vedotin.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in an early stage without significant spread.

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I was diagnosed before my 22nd birthday.

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I agree to use effective birth control during the study.

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I was diagnosed before my 26th birthday.

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My cancer is at a high-risk stage (IIB, IIIB, IV).

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I am a woman who has started menstruating and I have a negative pregnancy test.

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My cancer is stage IA or IIA with specific complications or is stage IB or IIIA.

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My lymphoma is at any stage according to the Ann Arbor classification.

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My liver tests are within the normal range for my age.

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My kidney function is good based on tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Response rate of adequate response

Secondary outcome measures

Event-free survival

Local failure rate

Number of adverse events in high-risk patients

+2 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Hypoglycemia

Dysphagia-esophageal radiation

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low-RiskExperimental Treatment10 Interventions

Participants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.

Group II: Intermediate-RiskExperimental Treatment10 Interventions

Participants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.

Group III: High-RiskExperimental Treatment9 Interventions

Participants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bendamustine

2012

Completed Phase 4

~1440

Etoposide

2010

Completed Phase 3

~2440

Doxorubicin

2012

Completed Phase 3

~7940

Bleomycin

2001

Completed Phase 3

~4960

Vincristine

2003

Completed Phase 4

~2910

Vinblastine

1998

Completed Phase 3

~5260

Prednisone

2014

Completed Phase 4

~2370

Filgrastim

2000

Completed Phase 3

~3670

Brentuximab Vedotin

2015

Completed Phase 4

~1070

Cyclophosphamide

1995

Completed Phase 3

~3770

DTIC

2005

Completed Phase 3

~2950

Radiotherapy

2017

Completed Phase 3

~2610

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor

208 Previous Clinical Trials

73,978 Total Patients Enrolled

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,363 Total Patients Enrolled

Teva Pharmaceuticals USAIndustry Sponsor

230 Previous Clinical Trials

187,958 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03755804 — Phase 2

Hodgkin's Lymphoma Research Study Groups: High-Risk, Low-Risk, Intermediate-Risk

Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03755804 — Phase 2

Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03755804 — Phase 2

Frequently Asked Questions

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

To what maladies is Radiotherapy typically employed?

"Radiotherapy is a recommended treatment for advanced testicular cancer and other medical issues, including pheochromocytomas, ulcerative colitis, as well as varicella-zoster virus acute retinal necrosis."

Answered by AI

Is the research being conducted groundbreaking in terms of its methodology?

"Since 1997, Radiotherapy has been researched extensively. Initially trialed by Alfacell in 1997 with 300 participants, the drug eventually achieved Phase 3 approval. Currently, 1537 trials are ongoing in 81 countries and 3149 cities around the world."

Answered by AI

Are there any other research projects that have explored the use of Radiotherapy?

"Radiotherapy was initially studied in 1997 at the Spectrum Health Hospital - Butterworth Campus. To date, there have been 2870 completed trials and 1537 that are still recruiting participants, mainly located in Charlotte, North carolina."

Answered by AI

Is there currently an open recruitment period for this experiment?

"Affirmative. Clinicaltrials.gov details reveal this medical trial is actively in search of participants since its inception on December 12th 2018, with the most recent edit being August 2nd 2022. The study requires 250 patients from 7 locations to be recruited for the experiment."

Answered by AI

How many locations are hosting this research experiment?

"Eligible patients can sign up for this trial at St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital in Charlotte, North carolina, Dana Farber Cancer Institute in Palo Alto, California and Lucile Packard Children's Hospital Stanford University in Memphis Tennessee as well as 7 other facilities."

Answered by AI

What is the present participant count of this research?

"Indeed, based on the information posted to clinicaltrials.gov, this experiment is actively recruiting participants at 7 locations with a total quota of 250 individuals. It was initially submitted in December 2018 and most recently updated in August 2022."

Answered by AI

What is the potential hazard of using radiotherapy in clinical practice?

"Radiotherapy's safety was assessed as a 2 on the 1-3 rating scale, given that Phase 2 trials have produced some evidence of its security but not any proof of efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

2018. "Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03755804.

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