Study:
Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL)
Rationale:
Giving low doses of chemotherapy before a donor stem cell transplant helps stop
the growth of cancer cells. It may also stop the patient`s immune system from rejecting the
donor`s stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. The donated stem cells may replace the patient`s immune cells and help destroy any
remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a
donor can also make an immune response against the body`s normal cells. Giving tacrolimus,
sirolimus, and methotrexate after the transplant may stop this from happening.
Purpose:
This phase II trial is studying how well donor stem cell transplant works in
treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
Leukemia
Lymphoma |
Biological: anti-thymocyte globulin
Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Other: laboratory biomarker analysis
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation |
Phase 2 |
Verified by
Cancer and Leukemia Group B
February, 2013
Sponsored by: Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01027000
Study Type: Interventional
Study Design: Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Edwin P. Alyea, MD., Study Chair