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

Pediatric Classical Hodgkin Lymphoma Consortium Study

Categories:

Leukemia / Lymphoma

Phase I/II

Long-term Effects

Diseases Treated:

Lymphoma

Eligibility Overview:

  • Previously untreated CD30+ classical Hodgkin lymphoma
  • 21 years or younger at time of diagnosis (low-risk and intermediate-risk patients)
  • 25 years or younger (high-risk patients)
  1. 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.

  2. 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 will we 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)
  3. cHOD17 Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT03755804
    Trial start date November 2018
    Estimated enrollment 200 (across all participating sites)
    Study type Interventional
    Study Phase Phase II
    Conditions Hodgkin lymphoma
    Ages Younger than 21
    Principal investigator Jamie Flerlage, MD, MS
    Study sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss cHOD17 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.