CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Cyclophosphamide +10 moredrug
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/NCT01904136
NCT01904136Phase 2Completed
CompareCT.gov

A Phase I/II Clinical Trial of NK Cells Administration to Prevent Disease Relapse for Patient With High-Risk Myeloid Malignancies Undergoing Haploidentical Stem-Cell Transplantation

M.D. Anderson Cancer Center·interventional·Posted Jul 22, 2013·Updated Jan 24, 2024

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation, and 9 other interventions for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 8 related conditions. Completed, enrolled 54 participants across 1 site.

Detailed Summary

This phase I/II studies the side effects and best dose of natural killer cells before and after donor stem cell transplant and to see how well they work in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia. Giving chemotherapy with or without total body irradiation before a donor peripheral blood stem cell or bone marrow 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 Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia With Gene Mutations, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Therapy-Related Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 22, 2013
Enrollment StartApr 22, 2014
Primary CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 12.9 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic PBSC or bone marrow transplant

Bone Marrow Transplantationprocedure

Undergo allogeneic PBSC or bone marrow transplant

Cyclophosphamidedrug

Given IV

Fludarabinedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given PO

Natural Killer Cell Therapybiological

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic PBSC or bone marrow transplant

Tacrolimusdrug

Given IV and PO

Total-Body Irradiationradiation

Undergo TBI