Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes
NCT02131597 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-07-17
Summary
This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions
- High Risk Myelodysplastic Syndrome
Interventions
- DRUG
-
Guadecitabine
Given SC
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Guillermo Garcia-Manero · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-10
- Primary Completion
- 2024-07-25
- Completion
- 2024-07-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia
NCT02920008 ·Status: COMPLETED ·Phase: PHASE3
-
Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS)
NCT02010645 ·Status: TERMINATED ·Phase: PHASE2
-
A Pilot Study of a Thrombopoietin-Receptor Agonist, Eltrombopag, in Patients With Low to Int-2 Risk Myelodysplastic Syndrome (MDS)
NCT00961064 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS
NCT02921061 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
NCT02348489 ·Status: COMPLETED ·Phase: PHASE3
-
5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT01041443 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Ultra Small Dose Decitabine for the Lower Risk MDS Patients With Transfusion Dependent
NCT03045510 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
NCT07006025 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome
NCT06304103 ·Status: RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT00002805 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
NCT01806116 ·Status: UNKNOWN ·Phase: PHASE4
-
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
NCT02044796 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
NCT00968071 ·Status: COMPLETED ·Phase: PHASE2
-
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
NCT04097470 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
NCT00882102 ·Status: COMPLETED ·Phase: PHASE2
-
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
NCT00043134 ·Status: UNKNOWN ·Phase: PHASE3
-
HCT With PTCy in Higher-risk MDS
NCT06098313 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
NCT00801489 ·Status: RECRUITING ·Phase: PHASE2
-
Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes
NCT00382200 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
NCT03383575 ·Status: RECRUITING ·Phase: PHASE2
-
Nivolumab With Chemotherapy in Refractory MDS
NCT03259516 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
NCT00416598 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant
NCT00986804 ·Status: COMPLETED ·Phase: PHASE1
-
Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
NCT00988715 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
NCT02159040 ·Status: TERMINATED ·Phase: PHASE2