At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15)
In Brief
A Phase 2 clinical trial evaluating Rituximab, Interleukin-2, and 4 other interventions for Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. Completed, enrolled 16 participants across 1 site.
Detailed Summary
In this study the investigators investigate a cell therapy strategy that could harness allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators have designed a novel lymphodepleting conditioning regimen followed by infusion of donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory lymphoid malignancies.
Study Details
Timeline
Interventions
375 mg/m\^2 administered intravenously (IV) weekly \* 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
subcutaneously administered 9 million international units (IU) every other day \* 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight \< 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
administered intravenously 1.5 to 8 \* 10\^7 cells/kg on Day 0 (day of NK cell infusion)
60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine.
1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion.
25 mg/m\^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through day -2).