Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02370888
Status:
TERMINATED
Last Update Posted:
2020-01-27
First Post:
2015-02-10
Brief Title:
Lenalidomide After Allo-Hematopoietic Cell Transplant HCT in Acute Myelogenous Leukemia AML and Myelodysplastic Syndromes MDS Subjects With Minimal Residual Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Maximally Tolerated Dose MTD Dose Limiting Toxicities DLTs and Safety Profiles of Increasing Doses of Lenalidomide After Allo-HCT in AML and MDS Subjects With Minimal Residual Disease MRD Detected by the CD34 Mixed Chimerism Analysis UF-BMT-MRD-101
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UF-BMT-MRD-101
Brief Summary:
The purpose of this study is to determine the maximum tolerated dose dose limiting side effects and the safety of increasing doses of lenalidomide in patients with AML and MDS who have a small amount of detectable disease after allogeneic stem cell transplant
Detailed Description:
All subjects entering the screening phase will receive a unique subject number This number will be used to identify the subject throughout the study Additional test to include physical examinations blood tests and if applicable pregnancy test will be performed as part of participation in this research study
Lenalidomide will be administered for a total of 42 days The starting dose will be 25 mg given orally every other day on days 1-21 of a 28-day cycle for 2 cycles Dose escalations and de-escalations will be made until the maximum tolerated dose is reached
The dose levels of lenalidomide will be as follows
Dose Level 1 25 mg
Dose Level 2 25 mg
Dose Level 3 5 mg
Dose Level 4 75 mg
Doses should be taken at approximately the same time each day
Subjects must be instructed to swallow lenalidomide capsules whole with water at the same time each day Do not break chew or open the capsules
Each subject will keep an accurate record of lenalidomide dosing on the Subject Dosing Diary This diary will be kept in the research record as source documentation of lenalidomide dosing Study personnel will review the dosing instructions with each subject at each study visit Subjects will be asked to bring any unused drug and empty drug containers to the study site at the next visit for reconciliation with the Subject Dosing Diary
Lenalidomide will be administered for a total of 42 days The starting dose will be 25 mg given orally every other day on days 1-21 of a 28-day cycle for 2 cycles Dose escalations and de-escalations will be made until the maximum tolerated dose is reached
The dose levels of lenalidomide will be as follows
Dose Level 1 25 mg
Dose Level 2 25 mg
Dose Level 3 5 mg
Dose Level 4 75 mg
Doses should be taken at approximately the same time each day
Subjects must be instructed to swallow lenalidomide capsules whole with water at the same time each day Do not break chew or open the capsules
Each subject will keep an accurate record of lenalidomide dosing on the Subject Dosing Diary This diary will be kept in the research record as source documentation of lenalidomide dosing Study personnel will review the dosing instructions with each subject at each study visit Subjects will be asked to bring any unused drug and empty drug containers to the study site at the next visit for reconciliation with the Subject Dosing Diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV-CL-AML-PI-002987 | OTHER_GRANT | Celgene Corporation | None |