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NCT01729104 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01729104: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01729104 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729104, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given in combination with lenalidomide and rituximab to patients with relapsed or refractory B-cell non-hodgkin lymphoma. The goal of Part 2 of this study is to learn if the drug combination can help to control B-cell non-hodgkin lymphoma. The safety of this drug combination will be studied in both parts. Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer cells to die. It is also designed to cause the immune system to attack cancer cells.
Primary Outcome
MTD defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose limiting toxicity (DLT) assessed during first course of each cohort (28 days), and refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-04-25 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 1 |
Why NCT01729104 stopped before completion
NCT01729104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01729104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729104 about?
NCT01729104 is a clinical study titled "Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma". The goal of Part 1 of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given in combination with lenalidomide and rituximab to patients with relapsed or refractory B-cell non-hodgkin lymphoma. The goal of Part 2 of this study is to learn if the drug comb...
What is the current status of trial NCT01729104?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2013-04-25. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT01729104?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01729104?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01729104's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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