CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
aldesleukin +4 morebiological
Likely dose
cyclophosphamide 60 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00274846
NCT00274846Phase 2Completed
CompareCT.gov

Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia

Masonic Cancer Center, University of Minnesota·interventional·Posted Jan 11, 2006·Updated Dec 28, 2017

In Brief

A Phase 2 clinical trial evaluating aldesleukin, therapeutic allogeneic lymphocytes, and 3 other interventions for Leukemia. Completed, enrolled 21 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2006
Enrollment StartMar 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.5 years ago

Interventions

aldesleukinbiological

10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses

therapeutic allogeneic lymphocytesbiological

Cells infused per kg. 1.5-8.0 x 10\^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10\^9

cyclophosphamidedrug

Days -5 and -4: 60 mg/kg

fludarabine phosphatedrug

Days -5 through -2: 25 mg/m\^2

in vitro treated peripheral blood stem cell transplantationprocedure

Day 0 infuse natural killer cells