Spots Global Cancer Trial Database for Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

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Trial Identification

Brief Title: Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Official Title: Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

Study ID: NCT00048412

Conditions

Myelodysplastic Disorders

Leukemia

Multiple Myeloma

Plasma Cell Dyscrasia

Lymphoproliferative Disorders

Interventions

FLUDARABINE

CAMPATH 1H

FK50

Stem Cell Collection and Infusion

Study Description

Brief Summary: 1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. 3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Detailed Description: This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments. The following will be given to the patient after admission: Day - 6: Total body irradiation Day - 5 to - 2: Fludarabine and Campath 1H Day - 1: Day of rest Day 0: Stem cell transplant (infusion)