NCT02684162

Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the complete response (CR) rate of guadecitabine (SGI-110) with or without donor lymphocyte infusion (DLI) either for the treatment of morphologic relapse or the presence of minimal residual disease (MRD) in patients with acute myeloid leukemia or myelodysplastic syndrome after hematopoietic stem cell transplantation in patients with AML and MDS (cohort 1 and 2). II. The relapse-free survival with the use of SGI-110 as maintenance therapy in patients with high risk acute myeloid leukemia or myelodysplastic syndrome after hematopoietic stem cell transplantation (cohort 3). SECONDARY OBJECTIVES: I. To determine the safety and toxicity of SGI-110 with or without DLI in this subject population. II. To evaluate overall response and survival. OUTLINE: Patients receive guadecitabine subcutaneously (SC) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive DLI intravenously (IV) over 10-30 minutes on day 6 of cycles 2, 4, and 6 in the absence of disease progression or unacceptable toxicity.

Conditions

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Recurrent Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Donor Lymphocytes	Given IV
DRUG	Guadecitabine	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-06-22
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2016-02-17
• Last updated: 2025-11-06
• Results posted: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study