A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation
Before treatment starts, you will have a complete physical exam, including blood (about 2
tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To
collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and
a small amount of bone marrow is withdrawn through a large needle. Women who are able to
have children must have a negative blood pregnancy test.
You will be treated with donor immune cells (T lymphocytes) that will specifically target
certain leukemia cells in your body. Each participant will receive two doses of donor cells,
60 days apart. The second dose will be given 60 days after the first dose, at a higher dose
level, as long as no serious side effects occur after the first dose and there is still
disease present. Four dose levels of PR1-specific T lymphocytes will be considered. Up to
30 patients will be treated in cohorts of 3, starting at the lowest dose level, and not
skipping an untried dose level when escalating. The trial will be stopped early if the
lowest dose level is found to be unacceptably toxic.
These cells will be given on an outpatient basis. After each donor cell infusions, you will
be followed once a week in the outpatient clinic for at least 1 month and then every 3
months for at least one year. You will have routine blood (about 2 tablespoons) and urine
tests at these visits. Participants experiencing side effects from their leukemia or
leukemia treatment may need to be hospitalized earlier.
You will also receive several other medications to help decrease the risk of infections
while your immune system is weak. These include preventative antibiotics, antiviral drugs,
and antifungal drugs.
Bone marrow samples will be taken before the second cell infusion, and then 8 weeks, 12
weeks, 6 months and 1 year after the second cell infusion.
This is an investigational study. A total of up to 30 patients will be take part in this
study. All will be enrolled at UTMDACC.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL)
Continuous reassessment, infusion day 0 and second infusion day 60+/- 7
Muzaffar H. Qazilbash, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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