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NCT01771107 · ClinicalTrials.gov registry record · Phase 1

Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01771107: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01771107 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01771107, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

Primary Outcome

Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.

Interventions

  • DRUG Doxorubicin Hydrochloride
  • DRUG Brentuximab Vedotin
  • DRUG Dacarbazine
  • DRUG Vinblastine
  • OTHER Pharmacological Study

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2013-03-08
Est. Completion 2024-03-21
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01771107 record still lists

NCT01771107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 5 interventions - of which Doxorubicin Hydrochloride is the first listed.

NCT01771107 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01771107 about?

NCT01771107 is a clinical study titled "Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma". This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a...

What is the current status of trial NCT01771107?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-03-08. Estimated completion is 2024-03-21.

What interventions are being tested in trial NCT01771107?

The interventions under investigation include: Doxorubicin Hydrochloride (DRUG), Brentuximab Vedotin (DRUG), Dacarbazine (DRUG), Vinblastine (DRUG), Pharmacological Study (OTHER).

Who is sponsoring clinical trial NCT01771107?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01771107's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01771107, the US trial registry maintained by the National Library of Medicine. NCT01771107 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.