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Sponsors and Collaborators: |
Baylor College of Medicine The Methodist Hospital System Texas Children's Hospital Center for Cell and Gene Therapy |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00048412 |
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Disorders Leukemia Multiple Myeloma Plasma Cell Dyscrasia Lymphoproliferative Disorders |
Drug: FLUDARABINE Drug: CAMPATH 1H Drug: FK50 Procedure: Stem Cell Collection and Infusion |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM) |
Estimated Enrollment: | 40 |
Study Start Date: | June 2000 |
This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.
The following will be given to the patient after admission:
Day - 6: Total body irradiation
Day - 5 to - 2: Fludarabine and Campath 1H
Day - 1: Day of rest
Day 0: Stem cell transplant (infusion)
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Conditions that increase treatment related mortality (need one or more to be eligible):
Exclusion criteria
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | George Carrum, MD | Baylor College of Medicine |
Study ID Numbers: | H8714, DIMSUM |
Study First Received: | October 30, 2002 |
Last Updated: | April 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00048412 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Fludarabine monophosphate Hemostatic Disorders |
Multiple Myeloma Leukemia Lymphatic Diseases Hemorrhagic Disorders Alemtuzumab Fludarabine Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Pharmacologic Actions Multiple Myeloma |
Leukemia Lymphatic Diseases Neoplasms Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Alemtuzumab Cardiovascular Diseases Fludarabine Lymphoproliferative Disorders Neoplasms, Plasma Cell |