Phase I/II Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Multiple, Mycosis Fungoides, Hodgkin's Lymphoma, Multiple Myeloma
Both
Non-Hodgkin's Lymphoma, Multiple, Mycosis Fungoides, Hodgkin's Lymphoma, Multiple Myeloma
Trial Information
Phase I/II Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4
Outcome Time Frame:
2 months
Safety Issue:
Yes
Principal Investigator
Abhinav Deol, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
2011-203
NCT ID:
NCT01609816
Start Date:
May 2012
Completion Date:
August 2015
Related Keywords:
- Non-Hodgkin's Lymphoma
- Multiple
- Mycosis Fungoides
- Hodgkin's Lymphoma
- Multiple Myeloma
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- hepatosplenic T-cell lymphoma
- intraocular lymphoma
- nodal marginal zone B-cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncutaneous extranodal lymphoma
- peripheral T-cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent small lymphocytic lymphoma
- refractory hairy cell leukemia
- refractory multiple myeloma
- small intestine lymphoma
- splenic marginal zone lymphoma
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult Hodgkin lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I multiple myeloma
- stage I small lymphocytic lymphoma
- stage IA mycosis fungoides/Sezary syndrome
- stage IB mycosis fungoides/Sezary syndrome
- stage II adult Hodgkin lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage II multiple myeloma
- stage IIA mycosis fungoides/Sezary syndrome
- stage IIB mycosis fungoides/Sezary syndrome
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III multiple myeloma
- stage III small lymphocytic lymphoma
- stage IIIA mycosis fungoides/Sezary syndrome
- stage IIIB mycosis fungoides/Sezary syndrome
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult T-cell leukemia/lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IVA mycosis fungoides/Sezary syndrome
- stage IVB mycosis fungoides/Sezary syndrome
- T-cell large granular lymphocyte leukemia
- testicular lymphoma
- Waldenström macroglobulinemia
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
