A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:5 - 17
Updated:10/28/2018
Start Date:September 7, 2017
End Date:October 29, 2021
Contact:Takeda Study Registration Call Center
Email:GlobalOncologyMedinfo@takeda.com
Phone:+1-866-835-2233

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An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as
well as recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent
chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric
participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).

The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is
being tested to treat pediatric participants who have advanced stage, newly diagnosed,
classical CD30+ HL. This study will assess the safety, tolerability, and anti-tumor activity,
as well as recommended dose of brentuximab vedotin in combination with a multiagent
chemotherapy regimen that is based on a current standard of care (SOC) first-line treatment
regimen for newly diagnosed HL.

The study will enroll approximately 55 evaluable participants. The study will be conducted in
2 phases, Phase 1 and Phase 2. Phase 1 study will enroll up to 12 participants to determine
the recommended dose. Once the recommended dose is identified additional participants will be
enrolled into phase 2 so that the total number of evaluable participants will be
approximately 55, including participants treated at recommended dose in Phase 1. Participants
will be enrolled in the following 2 dose Cohorts:

• Brentuximab vedotin 48 mg/m^2 or 36 mg/m^2 in combination with doxorubicin, vinblastine,
and dacarbazine.

Phase 1 has completed enrollment and Phase 2 is now open for enrollment.

This multi-center trial will be conducted in United States (US), Italy, Brazil, Japan,
Taiwan, Singapore, and Hong Kong. The overall time to participate in this study is
approximately 55 months, including the follow-up period. Participants will be followed for a
maximum of 30 days following the last dose of protocol therapy for a follow-up assessment and
will be followed for survival until death or study closure or a maximum of 2 years after
enrollment of the last participant.

Inclusion Criteria:

Each participant must meet all the following inclusion criteria to be enrolled in the
study:

1. Histologically confirmed CD30+ classical HL.

2. Advanced stage, newly diagnosed HL (Stage III and Stage IV disease).

3. Treatment-naive HL.

4. Have performance scores of greater than or equal to (>=) 50 for Lansky
Play-performance or Karnofsky Performance Status.

Exclusion Criteria:

1. Nodular lymphocyte predominant HL.

2. Known active cerebral/meningeal disease, including signs or symptoms of progressive
multifocal leukoencephalopathy (PML) or any history of PML.

3. Any sensory or motor peripheral neuropathy.

4. Symptomatic neurologic disease compromising normal activities of daily living or
requiring medications.
We found this trial at
5
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Salvador, Bahia 41253
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Salvador,
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