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Sponsors and Collaborators: |
Stanford University National Institutes of Health (NIH) |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00186615 |
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.
Condition | Intervention | Phase |
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Blood Cancer |
Procedure: nonmyeloablative allogeneic hematopoietic cell transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Hematopoietic Cell Transplantation Using a Nonmyeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies |
Estimated Enrollment: | 100 |
Study Start Date: | March 2003 |
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxsymal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.
(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
(D) Patient must be competent to give consent.
 Exclusion Criteria:(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
(B) Uncontrolled CNS involvement with disease
(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
(D) Females who are pregnant
(E) Organ dysfunction defined as follows:
(F) Karnofsky performance score < 60%
(G) Patients with poorly controlled hypertension on multiple antihypertensives
(H) Documented fungal disease that is progressive despite treatment
(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis
(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: BMT Referrals 650-723-0822 | |
Contact: Cancer Clinical Trials Office (650) 498-7061 cctoffice@stanford.edu | |
Principal Investigator: Robert Lowsky | |
Sub-Investigator: Karl G. Blume | |
Sub-Investigator: Richard T. Hoppe | |
Sub-Investigator: Laura Johnston | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: Judith Anne Shizuru | |
Sub-Investigator: Samuel Md Strober |
Principal Investigator: | Robert Lowsky | Stanford University |
Study ID Numbers: | BMT136, 78998, BMT153, NCT00185640, PO1 CA49605 |
Study First Received: | September 14, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00186615 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antilymphocyte Serum Hematologic Neoplasms Hematologic Diseases |
Neoplasms Neoplasms by Site Hematologic Neoplasms Hematologic Diseases |