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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 24
• Participant gender: Both

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: University of Texas, Southwestern Medical Center at Dallas
• Treatments: Alemtuzumab; Cyclophosphamide
• Last Updated: 2009-12-02

Criteria

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