Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Acute Myeloid Leukemia
- High Risk Acute Myeloid Leukemia
- High Risk Myelodysplastic Syndrome
- Minimal Residual Disease
- Myelodysplastic Syndrome
- Recurrent Acute Myeloid Leukemia
- Recurrent Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02684162
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Betul Oran M.D. Anderson Cancer Center