CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Aldesleukin +7 morebiological
Likely dose
Not stated in 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/NCT01823198
NCT01823198Phase 2Completed
CompareCT.gov

NK Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies

M.D. Anderson Cancer Center·interventional·Posted Apr 4, 2013·Updated Nov 7, 2023

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Allogeneic CD56-positive CD3-negative Natural Killer Cells, and 6 other interventions for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 14 related conditions. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Erythroid Leukemia, Acute Megakaryoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts Under 20 Percent of Bone Marrow Nucleated Cells, Blasts Under 20 Percent of Peripheral Blood White Cells, Chronic Myelomonocytic Leukemia, High Risk Myelodysplastic Syndrome, Myelodysplastic Syndrome, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Therapy-Related Acute Myeloid Leukemia, Therapy-Related Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartJun 11, 2013
Primary CompletionMay 10, 2022
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 13.2 years ago

Interventions

Aldesleukinbiological

Given SC

Allogeneic CD56-positive CD3-negative Natural Killer Cellsbiological

Given IV

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic PBSC transplant

Busulfandrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic PBSC transplant

Pharmacological Studyother

Correlative studies