A Study to Evaluate the Safety and Efficacy of Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT00918463 | Terminated Phase 2 Results

• 1 other identifier: 0809009979
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

lymphoma; diffuse; refractory

Outcome Measures

Primary Outcomes (1)

• Response Rate

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

  2 years

Secondary Outcomes (2)

• 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

Study Arms (1)

all patients

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

100 mg daily dosing

Also known as: Sprycel

all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• Life expectancy of \> = 90 days (3 months).
• Ability to take oral medication: dasatinib tablets may be swallowed as a whole.
• Adequate organ function:
• Total bilirubin \<2.0 times Upper Limit of Normal (ULN) Serum Na, K, Mg, Phos, and Ca \> Lower Limit of Normal (LLN) Hemoglobin, neutrophil count, platelets, PT/PTT all grade 0-1 Serum creatinine concentration \<1.5 x institutional upper limit of normal (ULN). Serum SGOT/AST or SGPT/ALT \< 2.5 x institutional upper limit of normal (ULN).
• Concomitant medications:
• Patient agrees to discontinue St. Johns Wort while receiving dasatinib

You may not qualify if:

• 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
• Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
• 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) clinically significant gastrointestinal bleeding

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Peter Martin
• Organization: Weill Cornell Medicine

pem9019@med.cornell.edu

Study Officials

• Rebecca Elstrom, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 23, 2011
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Locations

US (1)