|
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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare available for their 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 condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > 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  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
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
For Condition: Graft Failure
Status: Terminated
Sponsor(s): Baylor College of Medicine , The Methodist Hospital,Texas Children's Hospital
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Diagnosis of engraftment failure either primary or secondary, following allogeneic transplantation. Graft failure is defined as absolute neutrophil count < 500/mm3 and/or platelet count < 20,000/mm3. Primary graft failure is defined as failure to maintain absolute neutrophil count > / = 500/mm3 for 3 consecutive days following allogeneic transplantation. Secondary graft failure is defined as failure to sustain an absolute neutrophil count > / = 500/mm3 after attainment of primary engraftment or failure to sustain platelet count > / = 20,000/mm3 despite neutrophil engraftment. For SCID patients, graft failure is defined as failure to recover > / = 500/mm3 T-cells and/or failure to generate satisfactory response to in vitro mitogen stimulation. For patients with genetic diseases, engraftment failure is defined as donor chimerism insufficient to correct or overcome the genetic or metabolic deficiency. - Available Healthy Donor without any contraindications for donation (5/6 or 6/6 related donor or 5/6 or 6/6 unrelated donor (molecular typing for DRB1) - Age between birth and 65 - For women of childbearing potential, negative pregnancy test EXCLUSION CRITERIA - Pregnant and lactating women or women unwilling to use contraception. - Uncontrolled intercurrent infection - Refractory AML or ALL - Untreated Blast Crisis for CML - Uncontrolled High-grade lymphoproliferative disease/lymphoma - Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) - Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) - Hemodialysis dependent - Active Hepatitis or cirrhosis with total bilirubin, SGOT, or SGPT greater than 3 x normal. - Concurrent solid organ malignancy not in remission, except for Stage 0 or A prostate cancer. - Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months) - Active CNS disease from hematological disorder.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
RobertKrance, Principal Investigator, Baylor College of Medicine
The Methodist Hospital
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, United States
United States
Additional Information:
Study ID Numbers: H9446; CAMGRAFT
Study Start Date: December 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048399
Other Graft Failure Studies:
1. 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
Related Studies:
Other Graft Failure Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
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
|
|
|
|
|
|
|
|
