Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Leukemia



Description: This study is for patients planning on being treated on a CALGB study for leukemia or myelodysplasia. Researchers from the Cancer and Leukemia Group B (CALGB) are attempting to better understand the causes of leukemia and myelodysplasia, and to develop improved methods for the diagnosis and treatment of these diseases. This study will allow the preservation and storage of a small portion of blood, bone marrow, and swabs of cells from the inside of the mouth from patients with these diseases. These materials will be used for the study of leukemia or myelodysplasia. In particular, the researchers are interested in studying particular molecules in the blood, bone marrow, and cheek cells. The exact molecules to be studied will change over time, and only the most promising will be chosen for investigation.


Hospitals Offering This Trial: Lombardi/Georgetown University Hospital, Washington Hospital Center

Contact: Jenny Crawford
Email: crawfojg@georgetown.edu
Phone: 202-687-0893


Title: CALGB 20202: Assessment of Noven Molecular Markers in Acute Myeloid Leukemia

Description: Subjects who have been diagnosed with acute myeloid leukemia (AML) are being asked to give some samples (specimens) are related information for research. Specimens being collected as part of this study are bone marrow, blood, and cheek cells. This may help researchers learn more about how to prevent, find and treat cancer and other diseases. In sonme instances, this study will be necessary to determine eligibility for specific treatment on a CALGB clinical trial. Samples will be stored for research in a Cooperative Group bank at The Ohio State University supported by the National Cancer Institute.


Hospitals Offering This Trial: Lombardi/Georgetown University Hospital

Contact: Jenny Crawford
Email: crawfojg@georgetown.edu
Phone: 202-687-0893


An Expanded Access Protocol for Idelalisib in Combination with Rituximab for Relapsed, Previously Treated Subjects with Chronic Lymphocytic Leukemia

This study is for patients with chronic lymphocytic leukemia (CLL) that has already been treated and currently requires treatment because it is growing and causing medical problems.

The purpose of this study is to provide early access to the drug Idelalisib to patients with CLL while it is being reviewed and approved by the Food and Drug Administration (FDA).

All subjects on this study will receive 8 infusions of the standard drug rituximab (every 2 weeks for 5 infusions and then every 4 weeks for a further 3 infusions and will take Idelalisib pills twice a day every day until their disease gets worse or they experience intolerable side effects.


Title: A Phase 2 Open-Label Study of the Efficacy of ABT 199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Description: This is a A Phase 2 Open-Label Study conducted to measure the Efficacy of ABT-199 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia in subjects who have the 17p ( a gene) Deletion.
The purpose of this study is to evaluate the efficacy (how well the study drug works) of ABT-199 monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) who have 17p deletion. The safety and tolerability of ABT-199 will also be evaluated. In addition, substances found in the blood, bone marrow and tissue (biomarkers) that may indicate the effects or progress of the leukemia and the activity of ABT-199 will be studied. Pharmacokinetics (how much ABT 199 is absorbed in your body at different times), pharmacogenetics (genetic differences that can affect individual responses to ABT-199) will also be evaluated.



Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

Description: This study is for patients with chronic lymphocytic leukemia (CLL) that has never been treated.

This research study is evaluating a study drug (not yet approved by the FDA), called idelalisib (also known as IDELA) in combination with the standard drugs, called rituximab and bendamustine, as a possible treatment for patients with CLL.

The purpose of this study is to find out if giving bendamustine, rituximab and idelalisib together is effective and safe for treating people with untreated CLL.

All subjects will receive bendamustine and rituximab by intravenous infusions. Subjects will be randomized (like the flip of a coin) to either idelalisb or placebo (a tablet that looks like idelalisib but contains no active medicine) that is taken twice a day.