Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

NCT03755804 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: cHOD17NCI-2018-02924
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 8

Brief Summary

This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma; Pediatric Cancer; Frontline Therapy; Response Adapted Therapy; Risk Adapted Therapy

Outcome Measures

Primary Outcomes (3)

• Response rate of adequate response

  The 70 evaluable low-risk patients enrolled will be evaluated for this objective.

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

• Response rate of adequate response

  The 65 evaluable intermediate-risk patients enrolled will be evaluated for this objective

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

• Event-free survival

  Time to event defined as relapse, progression or death. The 115 evaluable high-risk patients participants enrolled will be evaluated for this objective.

  From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

Secondary Outcomes (7)

• Number of adverse events in low-risk and intermediate-risk patients

  From enrollment to end of therapy (approximately 8 months

• Number of adverse events in high-risk patients

  From enrollment to end of therapy (approximately 8 months

• Local failure rate

  From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

• Event-free survival

  From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

• Response rate

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

Study Arms (3)

Low-Risk

EXPERIMENTAL

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.

Drug: bendamustine; Drug: Etoposide; Drug: Doxorubicin; Drug: Bleomycin; Drug: Vincristine; Drug: Vinblastine; Drug: Prednisone; Drug: Filgrastim; Other: Quality of Life Measurements; Radiation: Radiotherapy

Intermediate-Risk

EXPERIMENTAL

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.

Drug: bendamustine; Drug: Etoposide; Drug: Doxorubicin; Drug: Bleomycin; Drug: Vincristine; Drug: Vinblastine; Drug: Prednisone; Drug: Filgrastim; Other: Quality of Life Measurements; Radiation: Radiotherapy

High-Risk

EXPERIMENTAL

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.

Drug: Etoposide; Drug: Doxorubicin; Drug: Prednisone; Drug: Filgrastim; Drug: Brentuximab Vedotin; Drug: Cyclophosphamide; Drug: DTIC; Other: Quality of Life Measurements; Radiation: Radiotherapy

Interventions

bendamustine DRUG

Given intravenously (IV)

Also known as: TREANDA (R)

Intermediate-Risk; Low-Risk

Etoposide DRUG

Given intravenously (IV)

Also known as: VP-16, Vepeside

High-Risk; Intermediate-Risk; Low-Risk

Vinblastine DRUG

Given intravenously (IV)

Also known as: Velban (R)

Intermediate-Risk; Low-Risk

Prednisone DRUG

Given orally (PO)

Also known as: Prednisolone

High-Risk; Intermediate-Risk; Low-Risk

Filgrastim DRUG

Given subcutaneously (SQ) or IV

Also known as: Neupogen (R)

High-Risk; Intermediate-Risk; Low-Risk

Brentuximab Vedotin DRUG

Given intravenously (IV)

Also known as: Adcetris

High-Risk

Cyclophosphamide DRUG

Given intravenously (IV)

Also known as: Cytoxan (R)

High-Risk

Quality of Life Measurements OTHER

Quality of Life measurements may be done in low-risk cycles 1 and 2 BEABOVP, intermediate-risk cycles 1, 2 and 3 BEABOVP and high-risk cycles 1 and 2 AEPA and cycles 1, 2, 3, and 4 CAPDac. QOL may be done at year 1, 2 and 5 for all risk groups.

Also known as: Quality of Life Measurements (QOL)

High-Risk; Intermediate-Risk; Low-Risk

Radiotherapy RADIATION

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 for all risk groups. Radiotherapy will be administered after completion of all chemotherapy upon hematologic count recovery.

Also known as: radiation therapy, irradiation

High-Risk; Intermediate-Risk; Low-Risk

Doxorubicin DRUG

Given intravenously (IV)

Also known as: Adriamycin (R)

High-Risk; Intermediate-Risk; Low-Risk

Bleomycin DRUG

Given intravenously (IV)

Also known as: Blenoxane (R)

Intermediate-Risk; Low-Risk

Vincristine DRUG

Given intravenously (IV)

Also known as: Oncovin (R)

Intermediate-Risk; Low-Risk

DTIC DRUG

Given intravenously (IV)

Also known as: DACARBAZINE (R), Dimethyl Triazeno Imidazole Carboximide

High-Risk

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI).
• Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk
• Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their 26th birthday) for high-risk
• All Ann Arbor stages.
• Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)
• Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) and IB, IIIA.
• High-Risk: IIB, IIIB, IV
• Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted for age and gender as follows: Age 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for males and 0.6 mg/dL for females, Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for males and 0.8 mg/dL for females, Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females
• Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x ULN for age).
• Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease diagnosis
• Absolute neutrophil count (ANC) ≥1000/µL
• Platelets ≥ 75,000/µL
• Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or MUGA, unless decreased function is due to large mediastinal mass or effusion related to HL.
• Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 92% on room air unless secondary to a large mediastinal mass or effusion related to HL.
• Female participant who is post-menarchal must have a negative urine or serum pregnancy test.

You may not qualify if:

• CD30 negative HL.
• Has received prior therapy for Hodgkin lymphoma
• Inadequate organ function
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Teva Pharmaceuticals USA: collaborator
• Seagen Inc.: collaborator

Study Sites (8)

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

St. Jude Midwest Affiliate - Peoria

Peoria, Illinois, 61637, United States

Location

St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center)

Baton Rouge, Louisiana, 70809, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital

Charlotte, North Carolina, 28204, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

MeSH Terms

Conditions

Hodgkin Disease; Neoplasms

Interventions

Bendamustine Hydrochloride; Etoposide; Doxorubicin; Bleomycin; Vincristine; Vinblastine; Prednisone; Prednisolone; Filgrastim; Brentuximab Vedotin; Cyclophosphamide; Dacarbazine; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Oligopeptides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Therapeutics; Physical Phenomena

Study Officials

• Matthew Ehrhardt, MD, MS

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: December 12, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (8)