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

This study is currently recruiting participants.
Verified January 2011 by Weill Medical College of Cornell University

First Received on March 10, 2009.  
Last Updated on January 3, 2011  
History of Changes
This Clinical Trial Sponsored By: Weill Medical College of Cornell University
Collaborator: Bristol-Myers Squibb
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00918463
 

Purpose for Clinical Trial

This is a Clinical Trial 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.

Condition Study Intervention Phase
Diffuse Large B-cell Lymphoma Drug: dasatinib Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics:
Health Facilities
Lymphoma
Drug Information available for:
Dasatinib

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures For Clinical Trial:

  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • To evaluate the safety of dasatinib monotherapy as treatment for subjects with relapsed or refractory aggressive DLBCL. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine potential correlatives of response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: June 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: all patients Drug: dasatinib

100 mg daily dosing
Other Name: Sprycel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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:

    1. Patient agrees to discontinue St. Johns Wort while receiving dasatinib
    2. IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
  • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
  • Before starting study drug:
  • Female Subjects: FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative; Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study.
  • Male Subjects: Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy; Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.
  • During study participation and for 28 days following discontinuation from the study:
  • All Subjects: No more than a 30-day supply of study drug will be dispensed at a time.

Female Subjects:

  • FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.
  • In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit.
  • Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood.
  • Pregnancy testing

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