Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
- After the screening procedures confirm that the participant is eligible and willing to
participate in the research study, they will have the following tests and procedures.
- Dasatinib is given orally once daily. Each participant will have a pill diary to
record doses and any missed doses. All necessary drug refills will be given during
clinic appointments, at which time the pill diary and any unused study drug will be
returned.
- During the first month of study treatment the participant will come to the clinic at
the following intervals: Day 1: An EKG will be performed two hours after the first dose
of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4:
A physical examination, EKG and blood samples will be drawn once a week.
- Beginning with the second month of study treatment, participants will come to the
clinic monthly for up to two years. The following tests and procedures will be done;
physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG
(monthly for 6 months, then when medically indicated), CT of the neck, chest and
abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2,
additional blood will be drawn for research testing.
- Participants can continue to take the study drug for up to two years as long as their
disease does not progress and they are not experiencing any serious side effects.
Inclusion Criteria:
- 18 years of age or older
- CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and
CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
- Must have failed at least 1 prior fludarabine containing regimen or have failed at
least 2 non-fludarabine containing regimens or have a contraindication to fludarabine
use
- ECOG performance status of 2 or better
- Adequate organ function to tolerate chemotherapy
- Adequate method of contraception
Exclusion Criteria:
- Pregnant or breast-feeding women
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- History of clinically significant ventricular arrhythmias
- Prolonged QTc interval on pre-entry electrocardiogram
- Uncontrolled hypertension
- Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Patient known to be HIV positive
- Known significant bleeding disorder unrelated to CLL
- Drugs that interfere with platelet function or coagulation must be stopped at least 7
days prior to entry
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Objective Response Rate in Terms of Complete Response, Nodular Partial Response, and Partial Response to Treatment With Dasatinib for Patients With CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma).
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Philip Amrein, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
06-211
NCT ID:
NCT00438854
Start Date:
December 2006
Completion Date:
March 2013
Related Keywords:
- Chronic Lymphocytic Leukemia
- dasatinib
- BMS-354825
- CLL
- SLL
- LYN kinase
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
