Autologous NK cell infusions in treatment resistant CLL and CML - Protocol Description
If you (or someone you know) has CLL or CML that is not responding to standard treatments, you may be able to participate in our phase 1 clinical trial designed to evaluate the safety of a new type of cell transplant. Specifically, we are testing the safety and tolerability of the infusion of one type of your own white blood cells called NK cells.
In this research project your NK cells will be collected, reproduced in large numbers in the laboratory and then given back to you as an infusion. Before the cells are given back, you will receive two chemotherapy agents: pentostatin, to suppress your immune system and prevent it from attacking the infused NK cells, and bortezomib, to increase the anti-tumor activity of the NK cells. You will also receive the drug interleukin-2 to maintain NK cell activity. You are required to return to the Clinical Center for frequent safety monitoring over a 7 week period of protocol participation. If you respond you may have the option to continue NK cell infusions.
To find out if you qualify, please call us toll free at 1-800-411-1222 (TTY 1-866-411-1010). Our email address is BloodStudy@nhlbi.nih.gov
Natural History of MBL, CLL and SLL - Protocol Description
The Hematology Branch of the National Heart, Lung, and Blood Institute is conducting a clinical study for previously untreated patients with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Leukemia (SLL) or Monoclonal B cell lymphocytosis (MBL). Although all three diseases are considered a type of blood cancer involving B-lymphocytes, CLL involves the peripheral blood, SLL mostly involves the lymph nodes, and MBL is thought to be the earliest diagnostic stage of CLL/SLL.
Most patients with CLL/SLL/MBL do not require treatment at the time of diagnosis and are observed following a "watch and wait" approach. This study provides state of the art diagnostic workup, regular follow-up monitoring, and sample collection during the "watch and wait" period. If treatment becomes necessary, patients will receive information on possible standard treatment options and research studies available at NIH.
If you choose to participate, you will undergo tests and procedures designed to evaluate the status of your disease. You will also have the opportunity to donate blood and tissue samples that will be used in laboratory research experiments designed to help us better understand MBL/CLL/SLL.
If you or someone you know has been diagnosed with MBL, CLL, or SLL you (they) may be able to participate in this study. To find out if you qualify, please contact our research coordinator at (301) 402-0797 or email us at BloodStudy@nhlbi.nih.gov
Ofatumumab for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma - Protocol Description
The purpose of this study is to evaluate the efficacy of ofatumumab in combination with chemotherapy for previously untreated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL). Ofatumumab is FDA approved for treating CLL/SLL that is not responsive to other drugs.
Participants will receive treatment at the NIH Clinical Center Day hospital and will be regularly scheduled for clinic visits at the NIH to evaluate the response to treatment. There is no charge for study-related medications, laboratory tests or examinations. Financial support towards the cost of lodging and travel is available based on NIH guidelines.
For questions about this study, please contact the research coordinator, Tel. No. 301- 402-0797 or BloodStudy@nhlbi.nih.gov
PCI-32765 for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients 65 & older or have a 17p deletion - Protocol Description
This study will investigate the efficacy of PCI-32765 in patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) who are older than 65 or those patients with a 17p deletion. Recent studies indicated that PCI-32765 may inhibit cell proliferation. This protocol is intended both for patients who are untreated and those who have previously been treated. Oral PCI-32765 tablets will be distributed by the NIH and administered at the patient's home. Patients will be followed for a total of 12 months at the NIH. There is no charge for medications, laboratory tests, examinations, procedures and/or clinic visits performed as part of this study. If you have any questions about this study, contact the research nurse, Tel. No. (301)402-0797.