Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation

Completed · Phase 1

Conditions studied: Leukemia, Cancer

In brief

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.

Key facts

Study ID

NCT00586547

Run by

Baylor College of Medicine

People needed

11

Starts

2000-07-01

Expected to finish

2008-09-01

Last updated by the study team

2020-01-21

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Methodist Hospital — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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