Phase II Study of reduced-intensity allogeneic stem cell transplant for HR chronic lymphocytic leukemia (CLL)
ID Number 58-0056 (100701)Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to find out what effects (good and bad) this treatment has on you and your type of cancer. This research is being done to improve the outcomes of patients diagnosed with chronic lymphocytic leukemia who may have high risk features or who have had their disease return after receiving chemotherapy.
There is evidence that “stem cells” donated from a sibling (that is, a brother or sister) or another compatible person can be used as part of an effective therapy for CLL. After transplant into the patient, the donor’s stem cells (cells that have the ability to develop into red blood cells, white blood cells, or platelets) appear to have the ability to recognize and kill the patient’s leukemia cells. This powerful reaction performed by the donor’s stem cells is known as the “graft-versus-leukemia,” or GVL, effect.
In the past, stem cell transplantation required high doses of chemotherapy and/or radiation in the patient immediately prior to infusion of the donor’s stem cells. Success in controlling or eliminating cancer was believed to be the result of a combination of the high-dose chemotherapy/radiotherapy and the GVL effect described above. The high doses of chemotherapy and/or radiation and the serious side effects that result from it, restricted its use in young patients or patients without other significant medical problems. Recently, there has been success using lower doses of chemotherapy without radiation; the lower doses of chemotherapy have reduced and/or eliminated some of the serious side effects. When lower doses of chemotherapy without radiation are used, these types of transplants are referred to as “reduced intensity” transplants. The reduced intensity transplant in this study is considered standard, but the use of transplant early as an option for patients with high-risk features is considered experimental. The use of rituximab after the reduced intensity transplant is also considered experimental.
You may qualify to take part in this research study because you have been diagnosed with chronic lymphocytic leukemia (CLL) that either is considered to have high risk factors or has returned despite previous therapy. Patients considered to have CLL with high-risk features at diagnosis may not respond to standard chemotherapy.
Recruiting Patients: Yes