A Phase II, Single-Institution, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of a Single Agent Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Weill Medical College of Cornell University1 site in 1 country2 target enrollmentJune 2009

ConditionsDiffuse Large B-cell Lymphoma

Interventionsdasatinib

Drugsdasatinib

Overview

Phase: Phase 2
Intervention: dasatinib
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: Weill Medical College of Cornell University
Enrollment: 2
Locations: 1
Primary Endpoint: Response Rate
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase II, single institution, single-arm, open-label study of oral dasatinib monotherapy administered to subjects with relapsed or refractory aggressive DLBCL.

This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Research Hypothesis: Dasatinib, when administered orally at a continuous dose of 100 mg once daily, will be safe and effective in treating subjects that have failed prior therapies to diffuse large B cell lymphoma (DLBCL) or have relapsed disease.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 23, 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must understand and voluntarily sign an informed consent form.
•Must be \> = 18 years of age at the time of signing the informed consent form.
•Must be able to adhere to the study visit schedule and other protocol requirements.
•Biopsy-proven aggressive Diffuse Large B-Cell Lymphoma.
•Relapsed or refractory to previous therapy for lymphoma.
•Subjects must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.
•Subjects who have relapsed following an autologous stem cell transplant are eligible.
•Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
•Life expectancy of \> = 90 days (3 months).

Exclusion Criteria

•Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
•Subjects who are post allogeneic stem cell transplant.
•All subjects with active central nervous system (CNS) lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery who have remained asymptomatic for 90 days (3 months) and demonstrate, no CNS lymphoma, as shown by lumbar puncture, CT scan or MRI, are eligible. (If required, lumbar puncture, CT or MRI should be performed during screening process.) Subjects should not be receiving corticosteroids.
•Prior history of malignancies other than NHL (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> = 365 days (1 year).
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Known positive for HIV.
•Pregnant or lactating females.
•Concomitant Medications: 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
•Concurrent medical condition which may increase the risk of toxicity, including:
•Pericardial or pleural effusion of any grade

Arms & Interventions

all patients

Intervention: dasatinib

Outcomes

Primary Outcomes

Response Rate

Time Frame: 2 years

Response rate will be used as a measure of efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL)

Secondary Outcomes

To Evaluate the Safety of Dasatinib Monotherapy as Treatment for Subjects With Relapsed or Refractory Aggressive DLBCL.(2 years)
To Determine Potential Correlatives of Response.(2 years)