Clinical trial NCT00818961: Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
Official title: Reduced Intensity Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Summary: 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. 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 a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.
Interventions:
description: 43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9)
name: alemtuzumab
other_name: Campath
type: Biological
description: curative potential of allogeneic transplant results from the immune anti-tumor effect of donor cells or GVT/GVL
name: graft-versus-tumor induction therapy
type: Biological
description: in patients with Cd20+ malignancies: rituximab 375 mg/m*2 day -13. rituximab 1000 mg/m*2 on days, -6, +1, +8.
name: rituximab
other_name: Rituxan
type: Biological
description: For patients with AML, CML, MDS, MPS and ALL only: IV or oral busulfan may be given IV busulfan: 130 mg/m2 over 3 hours once daily on days -6, -5, -4 and -3 Oral busulfan: taken every 6 hours x 15 doses beginning on day -7 at 6pm and continuing through day -3 at 6am. 1 mg/kg test dose will be given prior to day -7 and PK samples will be drawn to calculate AUC.
name: busulfan
type: Drug
description: 750 mg/m2 infused over 1 hour once daily on days -5, -4 and -3. Cyclophosphamide will be started approximately 4 hours after the start of Fludarabine
name: cyclophosphamide
other_name: Cytoxan
type: Drug
description: For patients with CLL, NHL & HD: 30 mg/m2 infused over 30 minutes once daily on days -5, -4 and -3 For patients with AML, CML, MDS, MPS and ALL: 40 mg/m2 infused over 30 minutes once daily on days -6, -5, -4 and -3.
name: fludarabine phosphate
other_name: Fludara
type: Drug
description: 5 mg/m2 administered on days +1, +3 and +6
name: methotrexate
type: Drug
description: 0.03mg/kg/day infused over 24 hours starting on day -1 and switched to oral (twice daily divided dose) on day 14 or when able to tolerate PO
name: tacrolimus
other_name: Prograf; FK506
type: Drug
description: Recipients will receive an allogeneic transplant on day 0 after receiving high-dose chemotherapy. This trial uses matched unrelated donor stem cells.
name: allogeneic bone marrow transplantation
other_name: HSCT, allo transplant
type: Procedure
Study arms:
design_group_description: All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type
design_group_title: Hematopoietic Stem Cell Transplantation
design_group_type: Other
Sponsor: Northside Hospital, Inc.
Collaborators: Blood & Marrow Transplant Group of Georgia PC
Drug name mappings:
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 甲氨蝶呤钠
lang: CN
name: Methotrexate Sodium
lang: EN
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
name: 阿仑单抗
lang: CN
name: Alemtuzumab
lang: EN
name: アレムツズマブ（遺伝子組換え）
lang: JP