Study Stopped
Low accrual. No Analyses were performed
Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma
Phase I Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedStudy Start
First participant enrolled
February 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2018
CompletedMarch 16, 2020
March 1, 2020
3.7 years
May 30, 2012
March 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4
2 months
Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4
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).
2 months
Secondary Outcomes (1)
Incidence of large granular lymphocytes (LGL) lymphocytosis
6 months
Study Arms (1)
Dasatinib
EXPERIMENTALThis 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
Interventions
Patients receive dasatinib PO every day (QD) for 6 months.
Eligibility Criteria
You may qualify if:
- Recipients of first ASCT for the treatment of hematologic malignancies (multiple myeloma, Hodgkin's and non Hodgkin's lymphoma)
- Patients must be between 100 to 180 days after ASCT
- Dasatinib use prior to ASCT is allowed
- Performance status \>= 60%
- Total bilirubin \< 2.0 times the institutional upper limit of normal (ULN)
- Hepatic enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) =\< 2.5 times the institutional ULN
- Serum creatinine \< 1.5 times the institutional ULN
- Hemoglobin \>= 8 g/dL
- Absolute neutrophil counts \>= 1,500 cells per uL
- Platelets \>= 100,000 per uL
- Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
- Patient should be able to take oral medication (dasatinib must be swallowed whole)
You may not qualify if:
- Patients who have evidence of disease progression before day 100 after ASCT
- Sex and reproductive status:
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their partners are WOCBP
- Medical history and concurrent diseases:
- No malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years
- Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade at the time of screening for study
- Uncontrolled angina, congestive heart failure or myocardial infarction (MI) (within 6 months)
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 450 msec)
- History of significant bleeding disorder unrelated to cancer, including:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abhinav Deol, M.D.
Barbara Ann Karmanos Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 1, 2012
Study Start
February 12, 2015
Primary Completion
October 9, 2018
Study Completion
October 9, 2018
Last Updated
March 16, 2020
Record last verified: 2020-03