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Promising new combo for childhood hodgkin lymphoma shows high remission rates

NCT ID NCT02979522

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug combination (brentuximab vedotin plus standard chemotherapy) in 59 children with advanced, newly diagnosed Hodgkin lymphoma. The goal was to find the safest dose and see how well it shrinks tumors. Early results show many children achieved complete remission, but long-term disease control and possible side effects are still being monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

59 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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.

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Conditions

The condition(s) this trial relates to.

classic Hodgkin lymphoma Hodgkins lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hodgkin disease

Contacts and locations

Locations

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, 50139, Italy

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

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

    São Paulo, 04023-062, Brazil

  • Hospital Santa Marcelina

    São Paulo, 08270-070, Brazil

  • Hospital Sao Rafael S/A

    Salvador, Estado de Bahia, 41253-190, Brazil

  • ICr - Instituto da Crianca - HCFMUSP

    São Paulo, 05403-000, Brazil

  • INCA - Instituto Nacional de Cancer

    Rio de Janeiro, 20230-230, Brazil

  • Jardim das Americas

    Paranã, 81520-060, Brazil

  • NHO Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia

    Roma, 165, Italy

  • St. Marianna University School of Medicine Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.