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NCT01920932 · ClinicalTrials.gov registry record · Phase 2

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma

A Phase 2 study of Stage II Childhood Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma, sponsored by St. Jude Children's Research Hospital.

Active
Registry status
Phase 2
Development phase
77
Enrollment target
6
Study locations

NCT01920932: Active Phase 2 study of Stage II Childhood Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma, sponsored by St. Jude Children's Research Hospital.

NCT01920932 is a Phase 2 study of Stage II Childhood Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01920932, a Phase 2 study of Stage II Childhood Hodgkin Lymphoma and Stage III Childhood Hodgkin Lymphoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
77 participants
Enrollment target
6
Study locations

Study Summary

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Primary Outcome

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a tota

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • DRUG doxorubicin
  • DRUG brentuximab vedotin
  • DRUG etoposide

Study Locations (6)

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Dana-Farber Harvard Cancer Center - Boston

California

  • Lucile Packard Children's Hospital Stanford University - Palo Alto

Illinois

  • St. Jude Midwest Affiliate - Peoria

Maine

  • Maine Children's Cancer Program (MCCP) - Scarborough

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2013-08-12
Est. Completion 2028-05
Phase Phase 2

What the registry record for NCT01920932 still lists

NCT01920932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).

The record links to 3 conditions, with Stage II Childhood Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which prednisone is the first listed.

NCT01920932 lists 6 locations in 5 states (Massachusetts, California, Illinois).

Frequently Asked Questions

What is clinical trial NCT01920932 about?

NCT01920932 is a clinical study titled "Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma". This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some b...

What is the current status of trial NCT01920932?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2013-08-12. Estimated completion is 2028-05.

What conditions does trial NCT01920932 study?

This clinical trial studies the following conditions: Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma.

What interventions are being tested in trial NCT01920932?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), doxorubicin (DRUG), brentuximab vedotin (DRUG), etoposide (DRUG).

Who is sponsoring clinical trial NCT01920932?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01920932 being conducted?

This trial has 6 study locations across California, Illinois, Maine, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01920932's enrollment target sits among peer trials

77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01920932, the US trial registry maintained by the National Library of Medicine. NCT01920932 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.