A Phase I/II Study of Pyrimethamine, a STAT3 Inhibitor, for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Participants will be required to enroll in DFCI Protocol 99-224, the CLL Research
Consortium Tissue Bank, and DFCI Protocol 01-206, Tissue and Data Collection for
Research Studies in Patients with Hematologic Malignancies, Bone Marrow Disorders, and
Normal Donors, or may have blood banked for future use.
- Each treatment cycle lasts 28 days during which time participants will take
pyrimethamine orally once per day. Since we are looking for the highest dose of the
study drug that can be administered safely without severe or unmanageable side effects,
not everyone who participates will receive the same dose of study drug.
- The following tests and procedures will be performed at specific time points during
participation in the study: Physical exam, vital signs, blood tests and bone marrow
biopsy. The participant's tumor will be assessed by CT scans of the chest, abdomen and
pelvis prior to the start of the study and at the end of the 1st, 3rd and 6th months.
- Participants can continue to receive pyrimethamine as long as they do not have side
effects and their disease does not worsen.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To determine the maximum tolerated dose and recommended Phase 2 dose of pyrimethamine in relapsed CLL/SLL
Jennifer Brown, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|