A Phase 1 interventional study of Dasatinib and laboratory biomarker analysis in Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma and Myeloid Leukemia, sponsored by Barbara Ann Karmanos Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and Treatment
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.
This is a phase I, dose-escalation study.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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Patient should be able to provide signed written informed consent:
Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
Cardiac Symptoms; any of the following should be considered for exclusion:
History of significant bleeding disorder unrelated to cancer, including:
Prohibited treatments and or therapies:
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
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.
Drug: Dasatinib · Other: laboratory biomarker analysis
Patients receive dasatinib PO every day (QD) for 6 months.
Also known as: BMS-354825, Sprycel
Correlative studies
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) of dasatinib
Time frame: 2 months
Estimate the non-DLTs associated with administration of dasatinib in allogeneic stem cell transplantation (ASCT) recipients
Time frame: Up to 6 months post treatment
Estimate the incidence of large granular lymphocytosis (LGL) and its clinical course in recipients of ASCT
Time frame: Up to 6 months
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
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This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Barbara Ann Karmanos Cancer Institute