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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Myeloid Leukemia, Multiple Myeloma, Myelodysplastic Syndrome, Lymphoid Leukemia

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Trial Information

Phase I/II Study of Dasatinib in Recipients of Allogeneic 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 from related or unrelated donor for the treatment of
hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, acute
lymphoblastic leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome,
Hodgkin and non-Hodgkin lymphoma) who are 1-antigen or 1-allele mismatched or fully
matched at human leukocyte antigen (HLA)-A, -B, -C and -DR as defined by high
resolution typing

- Patients must be between 100 - 180 days after allogeneic stem cell transplantation

- Dasatinib use prior to ASCT is allowed

- Performance status >= 60%

- Presence of large granular lymphocyte (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 time the institutional ULN

- Hemoglobin >= 8 g/dL

- Absolute neutrophil count 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:

- Recipient of mismatched (allele or antigen level) graft in more than one loci of
HLAA, -B, -C or -DR loci will not be eligible, i.e. recipients of 2-antigen or
2-allelele mismatched graft

- Patients on investigational therapy for graft-versus-host disease (GVHD)

- Patients with uncontrolled acute or chronic GVHD or refractory disease not responding
to conventional therapy

- Patients who have evidence of disease progression before day 100 after ASCT

- 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

- 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 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 IV bisphosphonates will be withheld for the first 8 weeks of
dasatinib therapy due to risk of hypocalcemia

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (egg, 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:

Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) of dasatinib

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:

2011-204

NCT ID:

NCT01643603

Start Date:

May 2012

Completion Date:

December 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Myeloid Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Lymphoid Leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with del(5q)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • 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
  • de novo myelodysplastic syndromes
  • 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
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • 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 chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • 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 chronic lymphocytic leukemia
  • 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 small lymphocytic lymphoma
  • stage IA mycosis fungoides/Sezary syndrome
  • stage IB mycosis fungoides/Sezary syndrome
  • stage II adult Hodgkin lymphoma
  • stage II chronic lymphocytic leukemia
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • 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 chronic lymphocytic leukemia
  • 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 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 chronic lymphocytic leukemia
  • 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
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic
  • Hematologic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201