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

NCT ID: NCT02979522

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2029-09-24

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the 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).

Detailed Description

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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 at least 6 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 at least 55, including participants treated at recommended dose in Phase 1. Participants will be enrolled to the following initial dose cohort with an option to explore a reduced dose cohort at 36 mg/m\^2 if needed:

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

This multi-center trial will be conducted in the United States, Italy, Brazil and Japan. 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 and disease status every 12 weeks for 12 months, and then every 24 weeks until death or study closure or for up to 2 years from the date of the last participant enrolled.

Conditions

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Hodgkin Disease

Keywords

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Drug therapy, pediatric Hodgkin disease, frontline Hodgkin disease, advanced stage Hodgkin disease, pediatric lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD

Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.

Group Type EXPERIMENTAL

Brentuximab vedotin

Intervention Type DRUG

Brentuximab vedotin infusion

Doxorubicin

Intervention Type DRUG

Doxorubicin infusion

Vinblastine

Intervention Type DRUG

Vinblastine infusion

Dacarbazine

Intervention Type DRUG

Dacarbazine infusion

Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD

Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.

Group Type EXPERIMENTAL

Brentuximab vedotin

Intervention Type DRUG

Brentuximab vedotin infusion

Doxorubicin

Intervention Type DRUG

Doxorubicin infusion

Vinblastine

Intervention Type DRUG

Vinblastine infusion

Dacarbazine

Intervention Type DRUG

Dacarbazine infusion

Interventions

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Brentuximab vedotin

Brentuximab vedotin infusion

Intervention Type DRUG

Doxorubicin

Doxorubicin infusion

Intervention Type DRUG

Vinblastine

Vinblastine infusion

Intervention Type DRUG

Dacarbazine

Dacarbazine infusion

Intervention Type DRUG

Other Intervention Names

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Adcetris Adriamycin

Eligibility Criteria

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Inclusion Criteria

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.
5. Have bidimensional measurable disease as documented by radiographic technique per International Working Group (IWG) criteria.
6. Have adequate blood counts, renal and liver function as defined in the protocol.

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.
5. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks before the first study protocol therapy.
6. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of AVD.
7. Known human immunodeficiency virus positive.
8. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection, as determined by hepatitis B DNA or hepatitis C RNA, respectively, in blood.
9. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
10. Use of any strong or listed moderate cytochrome P450 (CYP) 3A4 inhibitors less than (\<) 2 weeks before the first dose of protocol therapy (please refer to the Study Manual for an example list of prohibited CYP3A4 inhibitors).
11. Any of the following cardiovascular conditions or values within 6 months before the first dose of protocol therapy:

* Shortening fraction of \<27 percent (%) by echocardiogram or, if echocardiogram not feasible, ejection fraction of \<50% by radionuclide angiogram (RNA or MUGA \[multiple-gated acquisition scan\]).
* New York Heart Association Class III or IV heart failure.
* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Hospital Sao Rafael S/A

Salvador, Estado de Bahia, Brazil

Site Status

Jardim das Americas

Paranã, , Brazil

Site Status

INCA - Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Site Status

GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer

São Paulo, , Brazil

Site Status

ICr - Instituto da Crianca - HCFMUSP

São Paulo, , Brazil

Site Status

Hospital Santa Marcelina

São Paulo, , Brazil

Site Status

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

Florence, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia

Roma, , Italy

Site Status

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

NHO Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Site Status

St. Marianna University School of Medicine Hospital

Kawasaki-shi, Kanagawa, Japan

Site Status

Countries

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Hong Kong Singapore Taiwan United States Brazil Italy Japan

References

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Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.

Reference Type DERIVED
PMID: 32596842 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-004112-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1171-0984

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506415-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

C25004

Identifier Type: -

Identifier Source: org_study_id