cHOD17: Risk-Adapted Therapy for Children and Young Adults with Hodgkin Lymphoma

Brief Summary

This is a multi-center, Phase II clinical trial utilizing risk-adapted, multi-agent treatment for children and young adults with classical Hodgkin lymphoma (HL).

Historically, children and adults with HL were treated with the same chemotherapy regimens, radiation therapy fields and doses. Due to the resulting late effects in childhood cancer survivors, we have developed a risk-adapted, combined modality treatment strategy for those patients with pediatric Hodgkin lymphoma.

Low-risk patients will be treated with two cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V backbone). Intermediate-risk patients will be treated with three cycles of BEABOVP. High-risk patients will receive two cycles of AEPA chemotherapy (brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride) and four cycles of CAPDac chemotherapy (cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine). Any patient who has an adequate response after the first 2 cycles of treatment will not receive radiation therapy.

Primary Objectives

• To evaluate the efficacy after two cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in low-risk and intermediate-risk patients with classical Hodgkin lymphoma
• To estimate the event-free survival in high-risk patients with classical Hodgkin lymphoma

Eligibility Criteria

Inclusion criteria include:

• Histologically confirmed, previously untreated CD30+ classical Hodgkin lymphoma (Participants are still eligible if they received limited emergent radiation therapy of steroid therapy, with a maximum of 7 days if within the last month, or as approved by the principal investigator.)
• 21 years or younger at time of diagnosis (low-risk and intermediate-risk patients)
• 18 years or younger (high-risk patients)

Exclusion Criteria include:

• CD30-negative Hodgkin lymphoma
• Has received prior therapy for Hodgkin lymphoma (except as specified above)
• Pregnancy
• Inadequate organ function

Study Sites

St. Jude Children’s Research Hospital, Memphis, Tennessee
Collaborating sites in and outside the U.S.

About this study

Hodgkin lymphoma is a cancer of the lymphatic system. The lymphatic system is comprised of tissue throughout the body that makes and stores infection-fighting cells.

Hodgkin lymphoma in children and young adults has a high cure rate. Patients are usually treated with chemotherapy (anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to kill cancer cells). Although most children are cured, some experience negative effects from treatment later in life. These kind of side effects are called “late effects” and can include problems with growth, problems with some organ functions and second cancers.

This study will adjust the standard therapy for Hodgkin lymphoma to find out if chemotherapy, plus a reduction in steroids and/or radiation treatments, can cure the cancer while reducing late effects.

Purpose of this clinical trial

The main goal of this study is to see if this approach can reduce treatment-related late effects in children and young adults with Hodgkin lymphoma.

Eligibility overview

• Previously untreated CD30+ classical Hodgkin lymphoma
• 21 years or younger at time of diagnosis (low-risk and intermediate-risk patients)
• 18 years or younger (high-risk patients)