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NCT01578967 · ClinicalTrials.gov registry record · NA

Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma

A NA study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
NA
Development phase
41
Enrollment target

NCT01578967 is a NA study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 41 participants.

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The verdict

NCT01578967, a NA study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
NA
Development phase
41 participants
Enrollment target

Study Summary

The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment. Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system. The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.

Interventions

  • DRUG Brentuximab vedotin
  • DRUG ABVD

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2012-04
Est. Completion 2020-12-11
Phase NA

What the Registry Record Tells You About NCT01578967

The ClinicalTrials.gov registry entry for NCT01578967 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Brentuximab vedotin is the first listed.

NCT01578967 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01578967 about?

NCT01578967 is a clinical study titled "Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma". The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, ...

What is the current status of trial NCT01578967?

This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2012-04. Estimated completion is 2020-12-11.

What interventions are being tested in trial NCT01578967?

The interventions under investigation include: Brentuximab vedotin (DRUG), ABVD (DRUG).

Who is sponsoring clinical trial NCT01578967?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.