CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Donor Lymphocytes +2 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/NCT02684162
NCT02684162Phase 2Completed

A Phase II Trial to Assess the Efficacy and Toxicity of SGI-110 With DLI for the Treatment of AML or MDS Relapsing After Allogeneic Stem Cell Transplantation

M.D. Anderson Cancer Center·interventional·Posted Feb 17, 2016·Updated Nov 6, 2025

In Brief

A Phase 2 clinical trial evaluating Donor Lymphocytes, Guadecitabine, and 1 other intervention for Acute Myeloid Leukemia and 4 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This phase IIa trial studies how well guadecitabine works in treating patients with acute myelogenous leukemia and myelodysplastic syndrome that has returned after a period of improvement after allogeneic stem cell transplant. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving guadecitabine before the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartJun 22, 2016
Primary CompletionOct 8, 2024
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.4 years ago

Interventions

Donor Lymphocytesbiological

Given IV

Guadecitabinedrug

Given SC

Laboratory Biomarker Analysisother

Correlative studies