Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Description

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

Study Overview

Study Details

Study overview

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.

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Condition
Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States, 94304

Peoria

St. Jude Midwest Affiliate - Peoria, Peoria, Illinois, United States, 61637

Baton Rouge

St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center), Baton Rouge, Louisiana, United States, 70809

Scarborough

Maine Children's Cancer Program, Scarborough, Maine, United States, 04074

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Charlotte

St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital, Charlotte, North Carolina, United States, 28204

Memphis

St. Jude Children's Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
  • * 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.

Ages Eligible for Study

to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

St. Jude Children's Research Hospital,

Matthew Ehrhardt, MD, MS, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

2028-07-01