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NCT02979522 · ClinicalTrials.gov registry record · Phase 1
A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
A Phase 1 study of Hodgkin Disease, sponsored by Takeda.
- Active
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 14
- Study locations
NCT02979522: Active Phase 1 study of Hodgkin Disease, sponsored by Takeda.
NCT02979522 is a Phase 1 study of Hodgkin Disease that is active but no longer recruiting, run by Takeda. The registered enrollment target is 59 participants, below the 275-participant average among 20 other Hodgkin Disease trials with a reported enrollment target (79% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02979522, a Phase 1 study of Hodgkin Disease, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 14
- Study locations
Study Summary
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).
Primary Outcome
The recommended dose was determined after considering all safety data in phase 1 and assessing for dose limiting toxicities (DLTs) which are defined as the dose range at which less than or equal to (\<=) 1 of 6 evaluable participants experience DLT within the defined observation period (Cycle 1 + 28 days). This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Brentuximab vedotin
- DRUG Dacarbazine
- DRUG Vinblastine
Study Locations (14)
Other
- Jardim das Americas - Paranã
- INCA - Instituto Nacional de Cancer - Rio de Janeiro
- GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer - São Paulo
- ICr - Instituto da Crianca - HCFMUSP - São Paulo
- Hospital Santa Marcelina - São Paulo
- Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer - Florence
- Fondazione IRCCS Policlinico San Matteo - Pavia
- Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia - Roma
- Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Torino
Colorado
- Children's Hospital Colorado - Aurora
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Estado de Bahia
- Hospital Sao Rafael S/A - Salvador
Aichi-ken
- NHO Nagoya Medical Center - Nagoya
Kanagawa
- St. Marianna University School of Medicine Hospital - Kawasaki-shi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2029-09-24 |
| Phase | Phase 1 |
What the registry record for NCT02979522 still lists
NCT02979522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 275-participant average among 20 other Hodgkin Disease trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Hodgkin Disease appearing as the primary indexed condition, and to 4 interventions - of which Doxorubicin is the first listed.
NCT02979522 lists 14 locations in 6 states (Other, Colorado, Ohio).
Frequently Asked Questions
What is clinical trial NCT02979522 about?
NCT02979522 is a clinical study titled "A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants 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 confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants...
What is the current status of trial NCT02979522?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2017-09-06. Estimated completion is 2029-09-24.
What conditions does trial NCT02979522 study?
This clinical trial studies the following conditions: Hodgkin Disease.
What interventions are being tested in trial NCT02979522?
The interventions under investigation include: Doxorubicin (DRUG), Brentuximab vedotin (DRUG), Dacarbazine (DRUG), Vinblastine (DRUG).
Who is sponsoring clinical trial NCT02979522?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02979522 being conducted?
This trial has 14 study locations across Colorado, Ohio, Estado de Bahia, Aichi-ken, Kanagawa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02979522's enrollment target sits among peer trials
59 13th of 20 higher than 8 of 20 other Hodgkin Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hodgkin Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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