Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I Clinical Trial to Evaluate Dimethylfumarate (DMF) in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
The purpose of the study is to investigate the safety of the investigational drug called
dimethylfumarate (DMF). DMF is a type of drug called an immunomodulatory drug. This drug is
approved by the United States (U.S.) Food and Drug Administration (FDA) as a treatment for
patient with multiple sclerosis.
Although there is evidence from tests on laboratory animals that DMF can decrease the number
of CLL cells, we do not know if this will work in humans with CLL. This drug will be given to
humans with CLL for the first time in this study. Therefore, the goal of this study is to see
if DMF is safe and tolerable in study participants. Participants will be evaluated to find
out what effects (good and bad) DMF has on the body and see how long the drug stays in the
body.
This is a phase I clinical trial to evaluate the safety, tolerability, and maximum tolerated
dose of DMF in patients with chronic lymphocytic leukemia. Patients with relapsed/refractory
CLL not amenable to available therapies are eligible. This patient population is in need of
novel therapies, particularly if progressing after, intolerant of, or unable to receive oral
tyrosine kinase inhibitors (ie ibrutinib, idelalisib).
For Dose Level 1, DMF (Tecfidera formulation) will be administered at a dose of 120 mg PO BID
(approximately 12 hours apart) for 2 x 28 day cycles.
For Dose Level 2, DMF will be administered at the currently used dose for patients with
multiple sclerosis: at the standard FDA approved dose of 120 mg PO BID (approximately 12
hours apart) for 1 week, then escalating to the assigned dose of (240mg PO BID for the
remainder of 2 x 28 day cycles. The 1 week lead-in at 120 mg is to assist in toleration and
initial side effects and is as per the standard prescribing information.
For Dose Level 3, DMF will be administered at the currently used dose for patients with
multiple sclerosis: 120 mg PO BID for 1 week, then escalate to the dose of 360mg PO BID for
the remainder of 2 x 28 day cycles.
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