Stem Cell Transplantation for Patients With Graft Failure Following an Allogeneic Transplant, Using Identical or Near Identical Donors and Less Toxic Conditioning With CAMPATH 1H
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|ClinicalTrials.gov Identifier: NCT00048399|
Recruitment Status : Terminated
First Posted : November 1, 2002
Last Update Posted : April 11, 2007
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 or disease||Intervention/treatment||Phase|
|Graft Failure||Drug: Fludarabine Drug: CAMPATH 1H Drug: FK506 Procedure: Stem Cell Transplantation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048399
|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|