NCT00176930

Stem Cell Transplant for Hematological Malignancy

Allogeneic Transplant for Hematological Malignancy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood. The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.

Detailed description

Preparative regimen using total body irradiation (TBI) and cyclophosphamide: 1. on day -6 and -5: cyclophosphamide is given, 2. on day -4, -3, -2, and -1: TBI is given, 3. on day 0: stem cell or bone marrow is infused. Alternate preparative therapy for patients not able to receive TBI The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system. l. Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. 2\. On day -9, -8, -7, -6 busulfan is given. 3\. On day -5, -4, -3, -2 cyclophosphamide is given. 4\. On day -1 no therapy is given (day of rest). 5\. On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed. Transplant: Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously. The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.

Conditions

• Leukemia, Myeloid, Chronic
• AML
• Leukemia, Lymphocytic, Acute
• MDS
• Leukemia, Lymphocytic, Chronic
• JMML
• Hodgkin's Disease
• Non-hodgkin's Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cell Transplant	Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
DRUG	Cyclophosphamide	60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
RADIATION	Total Body Irradiation	On Day -4, -3, -2, -1 total body irradiation is given twice daily.
DRUG	Busulfan	When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
DRUG	Equine ATG (ATGAM)	UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines
BIOLOGICAL	CD4+/CD25+ cells	On days -2, patients will receive CD4+/CD25+ cells intravenously.

Timeline

• Start date: 2001-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2005-09-15
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States