At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens
In Brief
A Phase 2 clinical trial evaluating ARA-C, BCNU, and 11 other interventions for Lymphoma and Leukemia. Completed, enrolled 22 participants across 1 site.
Detailed Summary
Primary objective: * To determine the safety of adback T- or Natural Killer (NK) cells in patients with lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH containing conditioning regimen. Secondary objective: * To determine the efficacy (disease-free-survival) of this strategy.
Study Details
Timeline
Interventions
100 mg/m\^2 IV Daily Over 1 Hour for 4 Days
300 mg/m\^2 IV Over 1 Hour for 1 Day
15 mg IV Daily Over 30 Minutes for 3 Days
1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days
100 mg/m\^2 IV Daily Over 3 Hours for 4 Days
30 mg/m\^2 IV Daily Over 1 Hour for 3 Days
100 mg/m\^2 IV Over 30 Minutes for 1 Day.
375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks.
Stem Cell Infusion on Day 0.
TBI on Day 5 following chemotherapy, before stem cell infusion.
5 mg/m2 IV on Days +1, +3, and +6.
0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.
Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.