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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00453206 |
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
Condition | Intervention | Phase |
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: anti-thymocyte globulin Drug: busulfan Drug: filgrastim Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: graft-versus-tumor induction therapy Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases |
Estimated Enrollment: | 40 |
Study Start Date: | February 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Quality of life is assessed at baseline.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hematological disease, including any of the following:
Chronic lymphocytic leukemia
Prolymphocytic leukemia
Non-Hodgkin's or Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia
Myelodysplastic syndromes
Chronic myelogenous leukemia
Polycythemia vera
Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
Chronic idiopathic myelofibrosis
Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria:
HLA-identical sibling (6/6)
9/10 matched related donor
10/10 matched unrelated donor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |||||
Wake Forest University Comprehensive Cancer Center | Recruiting | ||||
Winston-Salem, North Carolina, United States, 27157-1096 | |||||
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 |
Wake Forest University |
National Cancer Institute (NCI) |
Study Chair: | Yi-Kong Keung, MD | Wake Forest University Baptist Medical Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000538185, CCCWFU-29506, CCCWFU-IRB00001366 |
First Received: | March 27, 2007 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00453206 |
Health Authority: | Unspecified |
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