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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)
1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. 3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.
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)
Age
0 - 70 years
Sex
ALL
Healthy Volunteers
No
Texas Children's Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Start Date
June 1, 2000
Primary Completion Date
November 12, 2004
Completion Date
November 12, 2004
Last Updated
January 18, 2020
40
Estimated participants
FLUDARABINE
DRUG
CAMPATH 1H
DRUG
FK50
DRUG
Stem Cell Collection and Infusion
PROCEDURE
Lead Sponsor
Baylor College of Medicine
Collaborators
NCT00106925
NCT06179888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06152575