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| Sponsored by: |
Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00176930 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia, Myeloid, Chronic AML Leukemia, Lymphocytic, Acute MDS Leukemia, Lymphocytic, Chronic JMML Hodgkin's Disease Non-Hodgkin's Lymphoma Multiple Myeloma |
Procedure: Stem Cell Transplant Drug: Cyclophosphamide Radiation: Total Body Irradiation Drug: Busulfan |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Allogeneic Transplant for Hematological Malignancy |
| Estimated Enrollment: | 350 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Treatment Arm: Experimental
Patients receiving cyclophosphamide and total body irradiation (TBI) and transplant, or cyclophosphamide, Busulfan and transplant.
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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.
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, 1.0 mg/kg/dose by mouth every 6 hours.
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Preparative regimen:
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.
Eligibility| Ages Eligible for Study: | up to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Timothy Krepski | 612-273-2800 | tkrepski1@fairview.org |
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Daniel Weisdorf, MD 612-624-3101 weisd001@umn.edu | |
| Principal Investigator: | Daniel Weisdorf, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Masonic Cancer Center, University of Minnesota ( Weisdorf, Daniel J., MD ) |
| Study ID Numbers: | 0107M05202, MT2001-02, 2001LS049 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00176930 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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stem cell transplant chronic leukemia acute leukemia irradiation chemotherapy |
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Leukemia, Lymphoid Immunologic Factors Hematologic Neoplasms Blood Protein Disorders Paraproteinemias Cyclophosphamide Hemostatic Disorders Lymphoma, Small Cleaved-cell, Diffuse Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Alkylating Agents Hodgkin Disease Lymphoma Acute Lymphoblastic Leukemia |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases Blood Coagulation Disorders Myeloproliferative Disorders Vascular Diseases Hodgkin's Disease Leukemia, Myeloid Immunosuppressive Agents Multiple Myeloma Lymphatic Diseases Chronic Lymphocytic Leukemia Busulfan Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
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Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Immunologic Factors Hematologic Neoplasms Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Leukemia Neoplasms by Site Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses |
Cardiovascular Diseases Alkylating Agents Lymphoma Hodgkin Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Vascular Diseases Leukemia, Myeloid Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma |
