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NCT01979536 · ClinicalTrials.gov registry record · Phase 2
Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT01979536: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01979536 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01979536, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study Summary
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in targeted way and delivers vedotin to kill them. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy 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. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.
Primary Outcome
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm.
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Brentuximab Vedotin
- DRUG Cytarabine
- DRUG Crizotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2013-11-13 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 2 |
What the finished NCT01979536 record still lists
NCT01979536 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01979536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01979536 about?
NCT01979536 is a clinical study titled "Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma". This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic age...
What is the current status of trial NCT01979536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2013-11-13. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT01979536?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Brentuximab Vedotin (DRUG), Cytarabine (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT01979536?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01979536's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 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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