Epigenetic Reprogramming in Relapse/Refractory AML

Status Completed

Clinical Trial Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).

Clinical Trial Description

Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of demethylating agents and HDAC inhibitors in combination have been previously shown to have synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This study will ask the question as to whether or not the combination of decitabine and vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome in patients with relapsed or refractory acute myelogenous leukemia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03263936
Study type	Interventional
Source	Therapeutic Advances in Childhood Leukemia Consortium
Contact
Status	Completed
Phase	Phase 1
Start date	July 11, 2017
Completion date	February 10, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01200355` - Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome	Phase 4
Active, not recruiting	`NCT03755414` - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation	Phase 1
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Active, not recruiting	`NCT04188678` - Resiliency in Older Adults Undergoing Bone Marrow Transplant	N/A
Completed	`NCT02543879` - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies	Phase 1
Completed	`NCT01681537` - Lenalidomide Plus Chemotherapy for AML	Phase 1
Completed	`NCT01385423` - Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)	Phase 1
Terminated	`NCT01193400` - Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years	Phase 2
Completed	`NCT00981240` - Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes	Phase 1
Completed	`NCT00995332` - Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine	Phase 1/Phase 2
Completed	`NCT00975975` - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer	Phase 2
Completed	`NCT00726934` - The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients	N/A
Completed	`NCT00378534` - Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants	Phase 2
Completed	`NCT01031498` - Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting	Phase 2
Completed	`NCT00789256` - Low Dose Melphalan and Bortezomib for AML and High-Risk MDS	N/A
Completed	`NCT00098033` - Investigation of Clofarabine in Acute Leukemias	Phase 2
Completed	`NCT01020539` - Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia	Phase 1
Not yet recruiting	`NCT04709458` - Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis	Phase 1
Recruiting	`NCT04024241` - Medium Dose of Cytarabine and Mitoxantrone
Terminated	`NCT02203773` - Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)	Phase 1