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NCT01003769 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01003769: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT01003769 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003769, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or refractory B-CLL. - Funding Source - FDA OOPD
Primary Outcome
Maximum tolerated dose of lenalidomide when given in combination with AT-101, defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- DRUG R-(-)-Gossypol Acetic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-07-09 |
| Est. Completion | 2018-12-14 |
| Phase | Phase 1 |
Why NCT01003769 stopped before completion
NCT01003769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01003769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003769 about?
NCT01003769 is a clinical study titled "Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia". This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of improvement (relapsed). Biological ...
What is the current status of trial NCT01003769?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2015-07-09. Estimated completion is 2018-12-14.
What interventions are being tested in trial NCT01003769?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), R-(-)-Gossypol Acetic Acid (DRUG).
Who is sponsoring clinical trial NCT01003769?
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 NCT01003769's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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