Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02124174|
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS||Drug: Vidaza and Valproic Acid||Phase 2|
To assess the combination of valproic acid and azacitidine in preventing relapse in patients with high-risk Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplant. The primary objective of this study will be determining the 1 year overall survival from combining valproic acid (VPA) with 5-azacytidine (5-aza).
To assess the effect that adding valproic acid to azacitidine will have in patient with high-risk Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplant on the following endpoints
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Therapy With Azacitidine and Valproic Acid After Allogeneic Stem Cell Transplant in Patients With High-Risk Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)(Version 1_06 Jan 2012)|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Vidaza and Valproic Acid
Vidaza and Valproic Acid
Drug: Vidaza and Valproic Acid
Days 1-5: 5-Azacytidine 40 mg/m^2 daily Days 1-5: +Valproic acid 15 mg/kg daily Days 6-28: Valproic acid 15 mg/kg daily
*treatments will be repeated on the same days of each cycle for up to 4 total cycles. Each cycle will consist of 28 days.
- Survival [ Time Frame: 1 year ]Number of participants that survive post transplant for 1 year.
- Disease Relapse [ Time Frame: Day 0 to the day of first recurrance ]The time to relapse is from Day 0 to the day of first hematologic, cytogenetic, or radiological evidence of recurrent disease.
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): NCT02124174
|Contact: Mary Lee, BSNemail@example.com|
|Contact: Ceil Petrowsky, MSNfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Cardinal Bernardin Cancer Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Mary Lee, BSN|
|Contact: Ceil Petrowsky, MSN email@example.com|
|Principal Investigator: Patrick Stiff, MD|
|Principal Investigator:||Patrick Stiff, MD||Faculty|