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A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129)

Phase 1/Phase 2
19 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129)


- To determine the Maximum Tolerated Dose (MTD) of Dasatinib in relapsed or refractory
Non-Hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL

Secondary Objective:

- To assess the complete and overall response rates for all Phase I and Phase II patients
and to assay the levels of kinase activity in NHL specimens and correlate this activity
to patient outcomes.

- To determine overall survival and event free survival for all Phase I and Phase II

Treatment Plan

This study has two phases of treatment, Phase I and Phase II. The Phase I portion of the
trial will consist of a dose escalation plan with 3-6 patients being enrolled into each dose
cohort. The doses of Dasatinib used in Phase I are 100 mg, 150 mg, and 200 mg. The dose
that is found to be tolerated the best and also has the best treatment results will be used
for Phase II. An additional 29 patients will be enrolled into Phase II.

All patients will receive Dasatinib in this study. Dasatinib will be administered orally
(by mouth) once daily for 28 day cycles. A cycle will be considered 28 days. Dosing will
be continuous with no interruptions, unless instructed to interrupt treatment by the
treating physician.

The patient will be restaged after every 2 cycles of therapy, every even cycle. Therapy may
continue as long as there are no clinical signs of NHL progressing and the patient is
tolerating the treatment with no side effects related to the therapy. If the patient is
removed from study for any reason, he/she will be followed for survival until death.

Inclusion Criteria:

- Histologically confirmed diagnosis of non-hodgkin's lymphoma that is recurrent or
refractory after at least one prior therapy and for which no other potentially
curative therapy is available.

- Subject, age > or = 19 years

- Performance status (ECOG) 0-2

- Patients must have relapsed or refractory disease after at least one prior systemic
therapy, with at least a 3 week interval from the completion of the most recent
chemotherapy or radiotherapy regimen. Recover to ≤ grade 1 from all toxicities
related to the prior treatments is required.

- Patients must be ineligible or relapsed after an autologous or allogeneic stem cell
transplant if clinically appropriate.

- Adequate Laboratory Parameters:

- ANC ≥ 1000/μL

- Platelet count ≥ 50,000/μL

- Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)

- Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN

- Serum creatinine < 2.0 times the institutional ULN

- PTT within institutional normal limits

- Ability to take oral medication (dasatinib must be swallowed whole)

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (sensitivity < or = 25IU HCG/L) within 72 hours prior to the start of study drug

- Persons of reproductive potential must agree to use an adequate method of
contraception throughout treatment and for at least 6 months after study drug is

- Signed written informed consent including HIPAA according to institutional guidelines

Exclusion Criteria:

- No malignancy [other than the one treated in this study] which required systemic
treatment within the past 3 years.

- Concurrent medical condition which may increase the risk of toxicity, including:

- Clinically significant pleural or pericardial effusion

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

- Cardiac Symptoms, consider the following:

- Uncontrolled angina, congestive heart failure or 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)

- Subjects with hypokalemia or hypomagnesemia if it cannot be corrected

- 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 (< or = 3 months) significant gastrointestinal bleeding

- Concomitant Medications, consider the following prohibitions:

- 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.

- The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is
not recommended. The use of antacids should be considered in place of H2
blockers or proton pump inhibitors in patients receiving dasatinib therapy.

- Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy

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

- Patient may not be receiving any prohibited CYP3A4 inhibitors

- Women:

- Are unwilling or unable to use an acceptable method to avoid pregnancy for the
entire study period and for at least 4 weeks 6 months after cessation of study

- Have a positive pregnancy test at baseline

- Are pregnant or breastfeeding

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

after 1-28 day cycle of therapy

Safety Issue:


Principal Investigator

Julie Vose, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

September 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkins Lymphoma
  • Relapsed Non Hodgkins Lymphoma
  • Refractory Non Hodgkins Lymphoma
  • Dasatinib
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Nebraska Medical Center - Internal Medicine Section of Oncology/Hematology Omaha, Nebraska  68198-7680