Stem Cell Transplant for Hematological Malignancy
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.
Leukemia, Myeloid, Chronic
Leukemia, Lymphocytic, Acute
Leukemia, Lymphocytic, Chronic
Procedure: Stem Cell Transplant
Radiation: Total Body Irradiation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Transplant for Hematological Malignancy|
- Disease-Free Survival [ Time Frame: Long-term (1 and 2 year) ] [ Designated as safety issue: No ]is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
- Time to Neutrophil Engraftment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.
- Incidence of Acute Graft-Versus-Host Disease [ Time Frame: Day 100 ] [ Designated as safety issue: No ]Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host.
- Incidence of Chronic GVHD [ Time Frame: After Day 100 ] [ Designated as safety issue: No ]Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
- Persistence or relapse of malignancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]Defined as the return of disease after its apparent recovery/cessation.
- Overall Survival [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
- Engraftment Failure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Allogeneic stem cell transplant
Patients receiving cyclophosphamide and total body irradiation (TBI) and transplant, or cyclophosphamide, Busulfan and transplant.
Procedure: 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.)
Other Name: Bone Marrow Transplant.Drug: Cyclophosphamide
60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
Other Name: CytoxanRadiation: Total Body Irradiation
On Day -4, -3, -2, -1 total body irradiation is given twice daily.
Other Name: Radiation therapyDrug: Busulfan
When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
- on day -6 and -5: cyclophosphamide is given,
- on day -4, -3, -2, and -1: TBI is given,
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176930
|Contact: Timothy Krepskifirstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Daniel Weisdorf, MD 612-624-3101 email@example.com|
|Principal Investigator:||Daniel Weisdorf, MD||Masonic Cancer Center, University of Minnesota|