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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Multiple, Mycosis Fungoides, Hodgkin's Lymphoma, Multiple Myeloma

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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 InstituteDetroit, Michigan  48201