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Sprycel Medical Research Studies

Up-to-date List of Sprycel Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Sprycel Medical Research Studies

Rank Status Study
1 Recruiting Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia
Condition: Chronic Myelogenous Leukemia
Interventions: Drug: Zileuton (Zyflo®) Dasatinib (Sprycel®);   Drug: Dosing with Zileuton/Dasatinib in CML;   Drug: Daily dosing of Zileuton/Dasatinib;   Drug: Daily dosing with Zileuton/Dasatinib for CML
Outcome Measures: To determine the maximal tolerated dose (MTD) of zileuton when added to dasatinib in patients with CML;   To assess the efficacy of zileuton combined with dasatinib in terms of:
2 Recruiting A Study of Dasatinib in Chronic Lymphocytic Leukemia in Patients Who Exhibit in Vitro Dasatinib Sensitivity
Condition: Chronic Lymphocytic Leukemia (CLL)
Intervention: Drug: Dasatinib
Outcome Measures: Biologic target activity of dasatinib in CLL patients found to have pre-treatment in vitro dasatinib cytotoxicity (as defined by a ≥50% decrease in absolute lymphocyte count and/or lymph node size).;   Drug safety and tolerability of dasatinib in patients with CLL by assessing the number of participants with adverse events as a measure of safety and tolerability;   Overall Survival(OS);   Progression-free survival (PFS)
3 Recruiting Dasatinib and Crizotinib in Advanced Cancer
Condition: Advanced Cancers
Interventions: Drug: Crizotinib;   Drug: Dasatinib
Outcome Measures: Maximum tolerated dose (MTD) of Dasatinib plus Crizotinib;   Tumor Response
4 Recruiting Phase I/II - Dasatinib and Decitabine
Condition: Leukemia
Interventions: Drug: Dasatinib;   Drug: Decitabine
Outcome Measures: Maximum Tolerated Dose (MTD) Dasatinib and Decitabine;   Hematologic Responses During First 3 months of Treatment
5 Recruiting A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
Condition: Head and Neck Cancer
Interventions: Drug: Cetuximab;   Drug: Dasatinib;   Drug: Cisplatin;   Radiation: Radiation Therapy
Outcome Measures: Phase I is Efficacy and Safety. Phase II will be Tumor Response;   Phase I Tumor Response. Phase II Time on Treatment
6 Recruiting Study of Dasatinib in Patients With Chronic Myelogenous Leukemia
Condition: Chronic Myelogenous Leukemia
Intervention: Drug: Dasatinib (BMS-354825)
Outcome Measure: Time to first Molecular Response prior to 12 months (MMR)
7 Recruiting Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194
Condition: Breast Cancer
Intervention: Drug: Dasatinib and Paclitaxel
Outcome Measures: Phase I Portion: To determine the MTD of dasatinib when administered in combination with a fixed dose of weekly paclitaxel.;   Phase II Portion: To estimate efficacy (objective response rate; ORR; complete response (CR) + partial response (PR)) of dasatinib when administered in combination with weekly paclitaxel at the MTD established during the phase I portion of this trial.;   Phase I Portion: To obtain preliminary data on the therapeutic activity of dasatinib when administered in combination with weekly paclitaxel.;   Phase II Portion: To obtain safety and tolerability of dasatinib when administered in combination with weekly paclitaxel.;   Phase II: To estimate secondary efficacy endpoints of this combination including clinical benefit (CR+PR+SD > 6 months), time to tumor progression (TTP), progression free survival (PFS) and duration of response.;   Phase II: To obtain exploratory tumor biomarker data: assays of p-SRC, VEGFR2 and Collagen Type IV in plasma, obtained at baseline and after 2 cycles of treatment (8 weeks), will be performed by enzyme-linked immunosorbent assay.;   Phase II: To perform analysis of mRNA expression on the tumor specimens, for a gene expression profiling of the responders versus non-responders, in order to identify potential predictors of response to dasatinib.;   Phase II: To collect circulating tumor cells (CTC) at baseline and after 2 cycles of treatment (8 weeks);   Phase II: Exploratory somatic gene mutations detection in archived tumor samples
8 Recruiting Dasatinib in Treating Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Conditions: Non-Hodgkin's Lymphoma;   Hodgkin's Lymphoma;   Myeloid Leukemia;   Multiple Myeloma;   Myelodysplastic Syndrome;   Lymphoid Leukemia
Interventions: Drug: Dasatinib;   Other: laboratory biomarker analysis
Outcome Measures: Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) of dasatinib;   Estimate the non-DLTs associated with administration of dasatinib in allogeneic stem cell transplantation (ASCT) recipients;   Estimate the incidence of large granular lymphocytosis (LGL) and its clinical course in recipients of ASCT;   Perform correlative in vitro studies to see if the large granular lymphocytes show enhanced cytotoxicity to leukemia/ lymphoma cell lines
9 Not yet recruiting Explore the Synergy of Combination TKI Therapy
Condition: Healthy Volunteers
Interventions: Drug: Dasatinib;   Drug: Dasatinib+Imatinib
Outcome Measure: Area under the plasma concentration versus time curve (AUC) of dasatinib
10 Not yet recruiting Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)
Condition: Acute Myeloid Leukemia (AML)
Interventions: Drug: Dasatinib;   Drug: Cytarabine;   Drug: Daunorubicin
Outcome Measures: Event-free Survival;   Cumulative incidence of relapse (CIR);   Cumulative incidence of death (CID);   overall survival;   relapse-free survival;   PIA analysis;   toxicity
11 Unknown  A Study to Evaluate the Safety and Efficacy of Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Condition: Diffuse Large B-cell Lymphoma
Intervention: Drug: dasatinib
Outcome Measures: To determine the efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL). Efficacy will be assessed by measuring the response rate;   To evaluate the safety of dasatinib monotherapy as treatment for subjects with relapsed or refractory aggressive DLBCL.;   To determine potential correlatives of response.
12 Recruiting Dasatinib Combination for Chronic Lymphocytic Leukemia(CLL) With Refractory Disease
Condition: Chronic Lymphocytic Leukemia
Intervention: Drug: Dasatinib
Outcome Measures: response rate and response quality;   overall safety profile of these treatment approaches, event free survival, progression free survival, relapse or death, disease free survival
13 Recruiting Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma
Condition: Metastatic Melanoma
Interventions: Biological: DC vaccine;   Drug: Dasatinib
Outcome Measures: Increase of CD8+ T cell response from addition of dasatinib;   Number of participants with adverse events;   Tumor response;   PF and overall survival;   Number of CD8+ T cells infiltrating into melanoma lesions;   Number of suppressor cell populations and blood vessels in melanoma tumor biopsies;   Number of suppressor cell populations in patients peripheral blood;   Level of EphA2 protein expression in tumor biopsies;   Serum concentration of the T cell-recruiting chemokine CXCL10/IP-10
14 Recruiting Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)
Conditions: Lung Cancer;   Non-small Cell Lung Cancer (NSCLC)
Interventions: Drug: Dasatinib - 1A;   Drug: Afatinib - 1A;   Drug: Dasatinib - 1B;   Drug: Afatinib - 1B
Outcome Measures: Maximum Tolerated Dose (MTD) of BIBW 2992 in Combination with Dasatinib;   Objective Response Rate;   Progression Free Survival Rate
15 Recruiting Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Condition: Chronic Myeloid Leukemia
Intervention: Drug: Dasatinib
Outcome Measures: The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.;   Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
16 Recruiting Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies
Condition: Advanced Cancer
Interventions: Drug: Dasatinib;   Drug: Bevacizumab;   Drug: Paclitaxel
Outcome Measure: Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone
17 Unknown  Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia
Condition: Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Intervention: Drug: dasatinib
Outcome Measures: The efficacy of dasatinib;   To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission;   To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT
18 Recruiting Dasatinib in Treating Patients With Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma Previously Treated With Autologous Stem Cell Transplant
Conditions: Non-Hodgkin's Lymphoma;   Multiple;   Mycosis Fungoides;   Hodgkin's Lymphoma;   Multiple Myeloma
Intervention: Drug: Dasatinib
Outcome Measures: Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4;   Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4;   Incidence of large granular lymphocytes (LGL) lymphocytosis
19 Recruiting Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome
Conditions: Acute Myelogenous Leukemia;   Myelodysplastic Syndrome
Interventions: Drug: dasatinib (Sprycel);   Drug: all trans retinoic acid (VESANOID)
Outcome Measures: To determine the MTD and DLTs of dasatinib in combination with ATRA given the proposed dose escalation plan.;   Assessment of Differentiation. Bone marrow biopsies and aspirates will be obtained pre-treatment, on day 14, and day 28. These will be subjected to morphologic, cytochemical, and routine flow cytometric analyses.;   Assess treatment effects on SFK (Src family kinase) activation and expression of RARA target genes.;   PK parameters including peak concentration (Cmax),Tmax, Cmin, the area under the curve (AUC), volume of distribution, clearance terms, elimination rate constant, and elimination half-life (t1/2) will be analyzed.
20 Not yet recruiting Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Conditions: Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia;   Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia;   Untreated Adult Acute Lymphoblastic Leukemia
Interventions: Biological: blinatumomab;   Drug: prednisone;   Drug: vincristine sulfate;   Drug: methotrexate;   Drug: mercaptopurine;   Drug: dasatinib;   Other: laboratory biomarker analysis
Outcome Measures: Overall survival (OS) (Cohort I);   Incidence of dose-limiting toxicity, defined as any grade 3-4 non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) (Cohort II);   Complete response (CR + CRi) rate (Cohort I);   Disease-free survival;   Response rates (Cohort II);   OS (Cohort II);   Incidence of toxicity graded according to National Cancer Institute CTCAE version 4.0;   MRD negativity;   Time to achieve MRD negativity

These studies may lead to new treatments and are adding insight into Sprycel etiology and treatment.

A major focus of Sprycel research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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