CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes +1 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/NCT04620681
NCT04620681Phase 2Completed
CompareCT.gov

CD8 Depleted, Non-Engrafting, HLA Mismatched Unrelated Donor Lymphocyte Infusion in Patients With MDA and Secondary AML

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Nov 9, 2020·Updated Feb 19, 2026

In Brief

A Phase 2 clinical trial evaluating CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes and Standard of Care Chemotherapy for Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of the study is to determine the safety of an investigational treatment for myelodysplastic syndrome (MDS) after the first therapy (such as azacitidine or decitabine) stops working or after progression of MDS to acute myeloid leukemia (AML). Funding source - FDA OOPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes, Secondary Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 9, 2020
Enrollment StartJan 14, 2021
Primary CompletionJul 20, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.6 years ago

Interventions

CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytesbiological

Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent

Standard of Care Chemotherapydrug

Standard of care cytarabine-based chemotherapy