Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01609816|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Multiple Mycosis Fungoides Hodgkin's Lymphoma Multiple Myeloma||Drug: Dasatinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||August 2019|
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.
- 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 ]
- Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4 [ Time Frame: 2 months ]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 ]95% confidence intervals estimated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609816
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Abhinav Deol, M.D.||Barbara Ann Karmanos Cancer Institute|