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NCT02255162 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02255162: Clinical Trial Phase 1 study, sponsored by Massachusetts General Hospital.
NCT02255162 is a Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255162, a Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This research study is evaluating the safety and tolerability of the drug lenalidomide in combination with and following mismatched related donor microtransplantation in high risk AML patients in first remission. This study also aims to define the maximum tolerated dose (MTD) of lenalidomide given in this setting. Microtransplantation seeks to give the participant donor cells in hopes that those cells can attack the underlying cancer. However, since the donor cells do not replace all of the host cells, it can hopefully avoid many of the serious risks involved with standard transplant, including graft-vs.-host disease (GVHD) - a complication where the donor cells attack the participant's normal body. Recent studies have suggested that lenalidomide can help aid donor cells to attack cancer when given after a stem cell transplant. This trial is trying to see if lenalidomide can help encourage the attack of leukemia cells by donor cells given as part of microtransplantation. The FDA (the U.S. Food and Drug Administration) has approved lenalidomide but it has been approved for other uses such as in the treatment of other cancers including multiple myeloma and non-Hodgkin lymphoma. Although lenalidomide has been studied in patients with AML, it has not been approved by the FDA for standard use in AML. Lenalidomide is a compound made by the Celgene Corporation. It has properties which could demonstrate antitumor effects. The exact antitumor mechanism of action of lenalidomide is unknown.
Interventions
- DRUG Lenalidomide
- DRUG Cytarabine
- GENETIC HLA-mismatched stem-cell Microtransplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02255162
The ClinicalTrials.gov registry entry for NCT02255162 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.
NCT02255162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02255162 about?
NCT02255162 is a clinical study titled "Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML". This research study is evaluating the safety and tolerability of the drug lenalidomide in combination with and following mismatched related donor microtransplantation in high risk AML patients in first remission. This study also aims to define the maximum tolerated dose (MTD) of lenalidomide given i...
What is the current status of trial NCT02255162?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02255162?
The interventions under investigation include: Lenalidomide (DRUG), Cytarabine (DRUG), HLA-mismatched stem-cell Microtransplantation (GENETIC).
Who is sponsoring clinical trial NCT02255162?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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