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Clinical Trial Summary

This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether stable unrelated peripheral blood stem cell (PBSC) grafts can be safely established using nonmyeloablative pretransplant conditioning with intensified post-grafting immunosuppression and with every (q) 8 hours (hr) and possibly q 6 hr mycophenolate mofetil (MMF) dosing in patients with hematologic malignancies and renal cell carcinoma.

II. To determine if the incidence and severity of acute grades II-IV graft-versus-host disease (GVHD) can be reduced in patients with sustained engraftment with the use of q 8 hr MMF dosing.

SECONDARY OBJECTIVES:

I. To determine if engraftment can be maintained in patients with low chimerism and high risk of rejection with the use of a single dose of fludarabine (fludarabine phosphate) followed by donor lymphocyte infusion (DLI) on continued MMF/cyclosporine (CSP).

II. To compare survival and disease free survival to those achieved under protocol 1463.

OUTLINE:

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on days -4, -3, and -2 and undergo total-body irradiation (TBI) on day 0.

TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO every 8 hours on days 0-40 with taper to day 96.

After completion of study treatment, patients are followed up at 6 months, 1 year, 1.5 years, 2 years, and then annually thereafter. ;


Study Design


Related Conditions & MeSH terms

  • Adult Acute Myeloid Leukemia in Remission
  • Anemia
  • Carcinoma
  • Carcinoma, Renal Cell
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Myelodysplastic Syndrome
  • Childhood Renal Cell Carcinoma
  • Chronic Myelomonocytic Leukemia
  • Clear Cell Renal Cell Carcinoma
  • de Novo Myelodysplastic Syndrome
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Leukemia, Plasma Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Metastatic Renal Cell Cancer
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Previously Treated Myelodysplastic Syndrome
  • Progression of Multiple Myeloma or Plasma Cell Leukemia
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult Non-Hodgkin Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Non-Hodgkin Lymphoma
  • Refractory Anemia
  • Refractory Anemia With Ringed Sideroblasts
  • Refractory Childhood Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Renal Medullary Carcinoma
  • Syndrome
  • Type 1 Papillary Renal Cell Carcinoma
  • Type 2 Papillary Renal Cell Carcinoma
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia

NCT number NCT00027820
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 2001
Completion date September 5, 2004

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