Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02684162|
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia High Risk Acute Myeloid Leukemia High Risk Myelodysplastic Syndrome Minimal Residual Disease Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome||Biological: Donor Lymphocytes Drug: Guadecitabine Other: Laboratory Biomarker Analysis||Phase 2|
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 22, 2016|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Treatment (guadecitabine, DLI)
Patients receive guadecitabine SC 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 IV over 10-30 minutes on day 6 of cycles 2, 4, and 6 in the absence of disease progression or unacceptable toxicity.
Biological: Donor Lymphocytes
Other: Laboratory Biomarker Analysis
- Complete response (CR) rate (Cohort 1 and 2) [ Time Frame: After enrollment ]Up to 12 courses
- Relapse free survival (RFS) (Cohort 3) [ Time Frame: Up to 1 year ]The Bayesian method of Thall et al will be used to monitor RFS time in this cohort.
- Incidence of hematologic and non-hematologic toxicity [ Time Frame: Assessed up to 4 courses (16 weeks) ]Using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Will be tabulated within each subgroup (minimal residual disease and relapsed).
- Overall response rate [ Time Frame: Up to 12 courses (48 weeks) ]
- Duration of remission [ Time Frame: Duration of time from start of treatment to time of remission, assessed up to 12 courses (48 weeks) ]
- Incidence of acute graft versus host disease (GVHD) [ Time Frame: Up to day 6 of second course of guadecitabine (day 34) ]
- Incidence of chronic GVHD [ Time Frame: Up to 12 courses (48 weeks) ]
- Overall survival (OS) [ Time Frame: At 1 year ]Within each treatment cohorts, these events will be tabulated and the distributions of OS time estimated using the method of Kaplan and Meier.
- Disease-free survival time (DFS) [ Time Frame: At 1 year ]Within each treatment cohorts, these events will be tabulated and the distributions of DFS time estimated using the method of Kaplan and Meier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684162
|Contact: Betul Oran, MD||713-792-8750||BOran@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Betul Oran 713-792-8750|
|Principal Investigator: Betul Oran|
|Principal Investigator:||Betul Oran||M.D. Anderson Cancer Center|