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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

Must not have

High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active neurologic disease that would impede the ability to assess neurologic toxicities

Inability or unwillingness of research participant or legal guardian / representative to give written informed consent

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe nerve condition that affects my ability to assess nerve damage.

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I am unable or unwilling to give my consent for participation.

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My organs are not working properly.

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I have received treatment for Hodgkin lymphoma before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate of adequate response

Secondary study objectives

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

Dysphagia-esophageal radiation

Hypoglycemia

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)

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: 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

~1520

Etoposide

2010

Completed Phase 3

~2960