Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma
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 blood SCT. In this research study, researchers want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at the best dose of dasatinib.
|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 Autologous Stem Cell Transplantation for Hematologic Malignancies.|
- Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Defined as highest dose at which no more than one of dose limiting toxicity (DLT) is observed (among the first 6 patients treated and evaluable for toxicity for the purpose of cohort dose escalation decisions).
- Incidence of large granular lymphocytes (LGL) lymphocytosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]95% confidence intervals estimated.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||May 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. 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.
This is a phase I, dose-escalation study followed by a phase II study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609816
|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|