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NCT01461538 · ClinicalTrials.gov registry record · Phase 2
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
A Phase 2 study of Acute Myeloid Leukemia and Solid Tumors, sponsored by Seagen.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT01461538: Completed Phase 2 study of Acute Myeloid Leukemia and Solid Tumors, sponsored by Seagen.
NCT01461538 is a Phase 2 study of Acute Myeloid Leukemia and Solid Tumors that has completed, run by Seagen. The registered enrollment target is 84 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461538, a Phase 2 study of Acute Myeloid Leukemia and Solid Tumors, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Primary Outcome
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Conditions Studied
Interventions
- DRUG brentuximab vedotin
Study Locations (20)
Texas
- Texas Oncology - Bedford - Bedford
- Texas Oncology - Medical City Dallas - Dallas
- Texas Oncology - Dallas Presbyterian - Dallas
- Texas Oncology Denton South - Denton
- Texas Oncology - Fort Worth 12th Avenue - Fort Worth
- MD Anderson Cancer Center / University of Texas - Houston
California
- City of Hope - Duarte
- PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists - Oxnard
Florida
- Mayo Clinic Cancer Center - Jacksonville
- Ocala Oncology Center - Ocala
Oregon
- Willamette Valley Cancer and Research / USOR - Eugene
- Northwest Cancer Specialists, P.C. - Tulatin
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
Indiana
- Indiana University Simon Cancer Center - Indianapolis
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01461538 record still lists
NCT01461538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (28% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which brentuximab vedotin is the first listed.
NCT01461538 names 20 study sites across 12 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01461538 about?
NCT01461538 is a clinical study titled "Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies". This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
What is the current status of trial NCT01461538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2011-10. Estimated completion is 2014-12.
What conditions does trial NCT01461538 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Solid Tumors, Acute Lymphoid Leukemia, Anemia, Refractory, With Excess of Blasts.
What interventions are being tested in trial NCT01461538?
The interventions under investigation include: brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT01461538?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01461538 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01461538's enrollment target sits among peer trials
84 93rd of 306 higher than 213 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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