Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

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

Interventions

DRUG

bendamustine

Given intravenously (IV)

DRUG

Etoposide

Given intravenously (IV)

DRUG

Doxorubicin

Given intravenously (IV)

DRUG

Bleomycin

Given intravenously (IV)

DRUG

Vincristine

Given intravenously (IV)

DRUG

Vinblastine

Given intravenously (IV)

DRUG

Prednisone

Given orally (PO)

DRUG

Filgrastim

Given subcutaneously (SQ) or IV

DRUG

Brentuximab Vedotin

Given intravenously (IV)

DRUG

Cyclophosphamide

Given intravenously (IV)

DRUG

DTIC

Given intravenously (IV)

OTHER

Quality of Life Measurements

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.

RADIATION

Radiotherapy

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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA

  collaborator INDUSTRY

• Seagen Inc.

  collaborator INDUSTRY

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-12

Primary Completion

2027-01-01

Completion

2028-07-01

FDA Drug

Yes

Countries

• United States

Study Locations