Cancer Clinical Trial
Official title:
A Phase I Trial Evaluating The Use of RFT5-dgA to Deplete Alloreactive Cells PriorTo Haploidentical Stem Cell Transplantation
NCT number | NCT00586547 |
Other study ID # | H-9033 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2000 |
Est. completion date | September 2008 |
Verified date | January 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of < / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease. - Myelodysplastic syndrome. - AML after first relapse or with primary refractory disease. - CML hemophagocytic lymphohistiocytosis (HLH) - Familial hemophagocytic lymphohistiocytosis (FLH) - Viral-associated hemophagocytic syndrome (VAHS) - X-linked lymphoproliferative disease (XLP) - Patients with Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy - Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor. - Donor cells should be collected and frozen before conditioning starts. Exclusion Criteria: - Patients with a life expectancy (< or = to 6 weeks) limited by diseases other than leukemia. - Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e. shortening fraction < 25%) - Patients with severe renal disease (i.e. creatinine clearance less than 40cc/1.73m2) - Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted) - Patients with severe hepatic disease (direct bilirubin greater than 3ug/dl or SGPT greater than 500ug/dl) - Patients with severe personality disorder or mental illness that would preclude compliance with the study - Patients with a severe infection that on evaluation by the Principal Investigator precluded ablative chemotherapy or successful transplantation - Patients with documented HIV positivity |
Country | Name | City | State |
---|---|---|---|
United States | Methodist Hospital | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | University of Texas, Southwestern Medical Center at Dallas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determining the number of donor lymphocytes given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin. | 100 | ||
Secondary | To measure their overall and disease free survival. | 1 year |
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