Clinical Trials Logo
  1. Home
  2. Acute Myelogenous Leukemia
  3. NCT02109744

Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients — AML  

Acute Myelogenous Leukemia Clinical Trial

Official title:
A Phase I/II Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients

Clinical Trial Summary

To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.

Clinical Trial Description

To determine the efficacy of decitabine followed by Rapamycin in previously untreated elderly patients not able to receive standard chemotherapy or in patients with relapsed or refractory AML, through measurement of Complete Remission (CR), Complete Remission Incomplete Platelet Recovery (CRp), Partial Remission (PR), and event free and overall survival (Arm A). To determine the safety of administration of decitabine with escalating doses of Ribavirin in elderly leukemia patients or patients with relapsed/refractory disease with M4/M5 subtypes anticipated to express high eukaryotic translation initiation factor 4E (eIF4E) at diagnosis (Arm B). To establish effect of these sequential treatments on expression of phosphoinositide 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt /mTOR) pathway proteins and on eukaryotic translation initiation factor 4E (eIF4E) activation through Western blot and phospho-flow methodologies. To correlate the clinical response with baseline expression of phospho-p70S6 Kinase/phosphorylated protein kinase B (pAKT) and with the in vitro inhibitory effects of mammalian target of rapamycin (mTOR) inhibition with rapamycin or ribavirin on the level of downstream effectors. To determine whether a leukemia stem cell phenotype is inhibited by the sequential administration of decitabine/rapamycin or decitabine/ribavirin. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02109744
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2014
Completion date January 1, 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 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 NCT00995332 - Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine Phase 1/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