Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Completed · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia, Graft vs Host Disease, Leukemia, Myelodysplastic Syndrome, Myeloid Leukemia
In brief
Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The ability of BMT to cure these conditions has been credited to the use of high doses of chemotherapy, radiation therapy, and the antileukemia effect of the transplant. Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation (TBI), it is a therapy associated with toxic side effects. These side effects are often deadly and have limited BMT for use in patients under the age of 55. In this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient. In order to decrease the toxic side effects associated with the transplant, researchers will not use chemoradiotherapy. Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect.
Key facts
- Study ID
- NCT00001637
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 28
- Starts
- 1997-09-29
- Expected to finish
- 2016-12-28
- Last updated by the study team
- 2019-12-17
Who can join
Age: 55 and older, up to 71. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patient or donor pregnant or lactating.
- Patient age less than 55, greater than 71 years.
- ECOG performance status of 3 or more. Psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
- Major anticipated illness or organ failure incompatible with survival from BMT.
- DLCO less than 40% predicted.
- Left ventricular ejection fraction less than 30% predicted.
- Serum creatinine greater than 2.5 mg/dl.
- Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal.
- HIV positive (donor or recipient). Donors who are positive for HBV, HCV, or HTLV will be used at the discretion of the investigator.
- Other malignant diseases liable to relapse or progress within 5 years.
- Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm).
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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