At a glance
ClinicalIndex Comparison Record- ✓Ages 50-75 years
- ✓Relapsed CML in chronic or accelerated phase after STI-571 (Gleevec) therapy
- ✓ALL in complete or partial remission (excluding T cell ALL)
- ✓AML in first complete or partial remission, including secondary AML from chemotherapy or prior hematologic disease
- ✕ECOG performance status ≥3
- ✕DLCO less than 60% predicted
- ✕Left ventricular ejection fraction less than 40% or any angina
- ✕Absolute lymphocyte count less than 300/mm³
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ex Vivo Selective Depletion of Alloreactive Donor T-Lymphocytes Using "RFT5-SMPT-dgA": Reducing GVHD Risk Associated With Matched, Nonmyeloablative, Stem Cell Transplant for Hematologic Malignancies in Older Adults
In Brief
A Phase 2 clinical trial evaluating RFT5-SMPT-dgA and Isolex system for Graft vs Host Disease and 9 related conditions. Completed, enrolled 23 participants across 1 site.
Detailed Summary
This study will evaluate the safety and effectiveness of stem cell transplantation in which the donors T lymphocytes have undergone "selective depletion." Certain patients with cancers of the blood undergo transplantation of donated stem cells to generate new and normally functioning bone marrow. In addition to producing the new bone marrow, the donor's T-lymphocytes also fight any tumor cells that might have remained in the body. This attack on tumor cells is called a "graft-versus-leukemia" (GVL) effect. However, another type of T-lymphocyte from the donor may cause what is called "graft-versus-host-disease" (GVHD), in which the donor cells recognize the patient's cells as foreign and mount an immune response to reject them. Selective depletion is a technique that was developed to remove the T-lymphocytes that cause harmful GVHD, while keeping those that produce the desirable GVL effect.
Study Details
Timeline
Interventions
A specific anti-interleukin-2 receptor immunotoxin
CD34 selection/ T cell depletion used this system