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NCT01075321 · ClinicalTrials.gov registry record · Phase 1
Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01075321: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01075321 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01075321, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.
Primary Outcome
The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported
Interventions
- OTHER laboratory biomarker analysis
- OTHER immunohistochemistry staining method
- DRUG lenalidomide
- DRUG everolimus
- GENETIC polymorphism analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2011-01-10 |
| Est. Completion | 2020-02-13 |
| Phase | Phase 1 |
What the finished NCT01075321 record still lists
NCT01075321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01075321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01075321 about?
NCT01075321 is a clinical study titled "Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma". RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma. PURPOSE: ...
What is the current status of trial NCT01075321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2011-01-10. Estimated completion is 2020-02-13.
What interventions are being tested in trial NCT01075321?
The interventions under investigation include: laboratory biomarker analysis (OTHER), immunohistochemistry staining method (OTHER), lenalidomide (DRUG), everolimus (DRUG), polymorphism analysis (GENETIC).
Who is sponsoring clinical trial NCT01075321?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01075321's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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