Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01893320|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2013
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Vosaroxin Drug: Decitabine||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome|
|Actual Study Start Date :||July 18, 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Vosaroxin + Decitabine
The first 6 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
Other Name: Dacogen
- Maximum Tolerated Dose (MTD) of Vosaroxin in Combination with Decitabine [ Time Frame: 21 days ]Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which <33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
- Overall Response Rate (ORR) [ Time Frame: 21 days ]ORR defined as Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi).
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): NCT01893320
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naval Daver, MD||M.D. Anderson Cancer Center|