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Sponsors and Collaborators: |
Baylor College of Medicine The Methodist Hospital System Texas Children's Hospital |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00048399 |
To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a preparative regimen for HLA-identical sibling blood stem cell transplantation (SCT).
To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a preparative regimen for matched unrelated or single antigen mismatched family donor marrow transplantation.
Condition | Intervention | Phase |
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Graft Failure |
Drug: Fludarabine Drug: CAMPATH 1H Drug: FK506 Procedure: Stem Cell Transplantation |
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 Graft Failure Following Allogeneic Transplantation Using MHC Identical or Near Identical Donors and Submyeloablative Conditioning With CAMPATH 1H (CAMGRAFT) |
Estimated Enrollment: | 40 |
Study Start Date: | December 2000 |
Study participants will receive the following treatment:
Day -5 to -2...Fludarabine 30mg/m2* and CAMPATH** 1H 10mg IV
Day -1.........Day of rest
Day 0..........Stem cell transplant (infusion)
Where possible, patients will receive peripheral blood stem cells. When peripheral stem cells are unavailable (e.g. from some unrelated donor centers) or insufficient, bone marrow will be substituted. If peripheral blood stem cell collection is performed, the donor will be stimulated with G-CSF for 5 days and cells collected and frozen until the stem cell target number is obtained prior to the patient beginning the therapy. If a bone marrow harvest is performed, this will be performed on Day 0 (infusion day). After transplantation, G-CSF 5 micrograms/kg/day will be administered SC from day 7 until granulocytes >1000/ul.
Because CAMPATH-1H infusions will provide a persisting level of antibody over the transplant period, it will contribute to anti-GvHD activity. Additional GVHD prophylaxis will consist of FK506 administered IV via continuous infusion over 24 hours from Day-2 until engraftment or when the patient is able to take by mouth, every 12 hours. This is continued until 6 months post-transplantation. The dose is then tapered every 2 weeks until discontinued. All patients will receive supportive care (prophylaxis for antimicrobial, antiviral, antifungal and Pneumocystis Pneumonia, transfusions of blood products and intravenous gamma globulin and routine laboratory testing of chemistry and complete blood counts) as per Cell and Gene Therapy Standard Operating Procedures (SOP).
Donor engraftment will be evaluated via standard bone marrow studies (cytogenetics/DNA studies for chimerism) on days 30, 60, 100, 180 and 365 post transplantation. If these studies reveal loss of donor cells on two consecutive studies and/or evidence of relapsing disease, the donor will undergo a peripheral blood stem cell harvest via G-CSF stimulation.
Ages Eligible for Study: | up to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert K. Krance, MD | Baylor College of Medicine |
Study ID Numbers: | H9446, CAMGRAFT |
Study First Received: | October 30, 2002 |
Last Updated: | April 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00048399 |
Health Authority: | United States: Food and Drug Administration |
Alemtuzumab Tacrolimus Fludarabine Fludarabine monophosphate |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |