Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Phase II Study of 5-azacytidine Maintenance After Allogeneic Hematopoietic Cell Transplantation for High-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Despite improvements in outcomes after Hematopoietic Cell Transplantation (HCT) for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), the risk of relapse remains high and is the most common cause of mortality after HCT. Moreover, treatment options for relapse after HCT are limited. Strategies to reduce relapse with maintenance therapy in patients who are at high risk are needed to improve survival. 5-aza is a hypomethylating agent that has shown immune modulating properties that may enhance the graft-versus-leukemia (GVL) effect, including upregulation of tumor-associated antigen and costimulatory molecule expression. Moreover, 5-aza has properties that suggest protection against graft-versus-host disease (GVHD) as well. Preliminary data shows that it is well tolerated and effective in clinical use for the treatment of AML or MDS relapse after HCT, as well as for maintenance therapy. This study will evaluate the use of 5-aza for maintenance after HCT in patients with AML or MDS with risk factors that are associated with a high risk for relapse.
Phase II study of 5-aza maintenance after allogeneic Hematopoietic Cell Transplantation (HCT)
for high-risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Early studies
indicate 5-aza is a hypomethylating agent that has shown immune modulating properties that
may enhance the graft-versus-leukemia (GVL) effect, including upregulation of
tumor-associated antigen and costimulatory molecule expression. 5-aza also has properties
that suggest protection against graft-versus-host disease (GVHD). The primary objective is to
evaluate relapse rate at one year. Secondary objectives will include the incidence of both
acute and chronic GVHD as well as relapse-free survival, overall survival and toxicity.
Correlatives will be performed to evaluate the effect of 5-aza maintenance on the immune
system.
Subjects must be transplant candidates with MDS or high risk characteristics of AML. Subjects
are consented, screened, then transplanted. Those showing complete response and no active
GVHD after transplant can proceed to maintenance with 5-aza. Bone marrow biopsies are
performed for response assessment after transplant as well as every three cycles (1 cycle=28
days) while on treatment. Dosing starts at 32mg/m2 and can be increased every 2 cycles
without a serious adverse event (SAE), or reduced per toxicity for up to 12 cycles.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04240002 -
A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1/Phase 2 | |
| Completed |
NCT02626715 -
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS
|
Phase 2 | |
| Completed |
NCT05488613 -
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
|
||
| Completed |
NCT02265731 -
Study Evaluating Venetoclax in Subjects With Hematological Malignancies
|
Phase 1/Phase 2 | |
| Terminated |
NCT02927938 -
Leukemia Stem Cell Detection in Acute Myeloid Leukemia
|
Phase 3 | |
| Completed |
NCT01772953 -
Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
|
Phase 2 | |
| Recruiting |
NCT03188874 -
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
|
||
| Completed |
NCT00071006 -
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
| Completed |
NCT04079296 -
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
|
Phase 1/Phase 2 | |
| Completed |
NCT04509622 -
A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)
|
Phase 3 | |
| Withdrawn |
NCT03699384 -
Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03613532 -
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
|
Phase 1 | |
| Completed |
NCT02252107 -
10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1
|
Phase 2 | |
| Terminated |
NCT02259348 -
Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
|
Phase 2 | |
| Terminated |
NCT01463410 -
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
|
N/A | |
| Completed |
NCT01242774 -
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
|
Phase 1 | |
| Terminated |
NCT02134782 -
Yoga Fatigue Study
|
N/A | |
| Completed |
NCT01685619 -
AML-MDS Novel Prognostic Tests Clinical Study
|
||
| Completed |
NCT03625505 -
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04266795 -
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
|
Phase 2 |