Dasatinib for Immune Modulation After Donor Stem Cell Transplant for Hematologic Malignancies
This study uses a drug called dasatinib to produce an anti-cancer effect called large granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as natural killer cells that remove cancer cells. Researchers think that dasatinib may cause large granular lymphocyte expansion to happen in patients who have received a blood stem cell transplant (SCT) between 3 to 15 months after the SCT. In this research study, researchers want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and how to estimate how often large granular lymphocytic cellular expansion happens at the best dose of dasatinib.
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Dasatinib in Recipients of Allogeneic Stem Cell Transplantation for Hematologic Malignancies.|
- Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) of dasatinib [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Estimate the non-DLTs associated with administration of dasatinib in allogeneic stem cell transplantation (ASCT) recipients [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: Yes ]
- Estimate the incidence of large granular lymphocytosis (LGL) and its clinical course in recipients of ASCT [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Perform correlative in vitro studies to see if the large granular lymphocytes show enhanced cytotoxicity to leukemia/ lymphoma cell lines [ Time Frame: Prior to day 1 administration of dasatinib and thereafter every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
This is a phase 1 dose escalation study, using a standard 3+3 design. Dasatinib is administered orally once daily in the outpatient setting. Patients who are day 100-180 post transplant will be eligible. The treatment will be started as close to day 100 as possible. The range of days is provided to ensure that patients have recovered from toxicities associated with ASCT and are not deemed ineligible if they were recovering from any toxicity associated with ASCT at day 100.The starting dose of dasatinib is 20 mg daily. The increment of dose escalation is 20 mg per dose level. Thus, there will be 5 dose levels (20 mg, 40 mg, 60 mg, 80 mg and 100 mg, respectively) with 3 patients in each cohort. Patients will continue on dasatinib for 6 months.
Patients receive dasatinib PO every day (QD) for 6 months.
Other Names:Other: laboratory biomarker analysis
This is a phase I, dose-escalation study followed by a phase II study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643603
|Contact: Abhinav Deol, M.D.||email@example.com|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Clinical Trials Office 800-527-6266|
|Sub-Investigator: Lois Ayash, M.D.|
|Sub-Investigator: Lawrence Lum, M.D.|
|Sub-Investigator: Voravit Ratanatharathorn, M.D.|
|Sub-Investigator: Charles Schiffer, M.D.|
|Sub-Investigator: Joseph Uberti, M.D.|
|Sub-Investigator: Divaya Bhutani, M.D.|
|Principal Investigator: Abhinav Deol, M.D.|
|Principal Investigator:||Abhinav Deol, M.D.||Barbara Ann Karmanos Cancer Institute|