Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma



Status:Active, not recruiting
Conditions:Blood Cancer, Infectious Disease, Lymphoma, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:May 2012
End Date:August 2019

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Phase I/II Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation 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 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.

This is a phase I, dose-escalation study followed by a phase II study.

Inclusion Criteria:

- 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%

- Presence of LGL clone prior to enrollment will not be an exclusion criterion if the
LGL clone is < 25% of T cell population

- 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)

Exclusion Criteria:

- 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

- Cardiac symptoms; any of the following should be considered for exclusion:

- 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:

- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)*
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies)

- Ongoing or recent (=< 3 months) significant gastrointestinal bleeding

- Any previous history of >= grade 3 toxicity to dasatinib

- 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):

- Quinidine, procainamide, disopyramide

- Amiodarone, sotalol, ibutilide, dofetilide

- Erythromycin, clarithromycin

- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

- Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
(discontinue St. Johns Wort at least 5 days before starting dasatinib)

- Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first 8
weeks of dasatinib therapy due to risk of hypocalcemia

- Other exclusion criteria:

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness
We found this trial at
1
site
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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mi
from
Detroit, MI
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