Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03318016
Status:
TERMINATED
Last Update Posted:
2021-04-30
First Post:
2017-10-18
Brief Title:
Arsenic Trioxide With Cyclophosphamide in Patients With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Phase I Trial of Arsenic Trioxide With Cyclophosphamide in Patients With RelapsedRefractory Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment University Scientific Review Committee required study closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine the maximum tolerated dose MTD and toxicity profile of the combination of cyclophosphamide and ATO Arsenic Trioxide in subjects with relapsed refractory AML
Determine the efficacy of ATO and cyclophosphamide in this population as defined by response rate response duration event-free survival EFS and overall survival OS
Determine the number of transplant-eligible subjects who are successfully bridged to stem cell transplantation or donor lymphocyte infusion
Determine the efficacy of ATO and cyclophosphamide in this population as defined by response rate response duration event-free survival EFS and overall survival OS
Determine the number of transplant-eligible subjects who are successfully bridged to stem cell transplantation or donor lymphocyte infusion
Detailed Description:
This is an open label phase 1 study of fixed dose ATO Arsenic Trioxide and escalating doses of cyclophosphamide using a standard 33 dose escalation design All subjects will be treated with sequential cycles of 3 days of ATO at 015 mgkgd IV followed by Cyclophosphamide as a single IV dose on day 4 along with mesna at a dose equal to the cyclophosphamide for doses 1000 mgm2 and hydration for a maximum of 6 cycles ATO and Cyclophosphamide will be repeated every 28-42 days Treatment will be given inpatient for the first cycle with the option of outpatient treatment for subsequent cycles Subjects may remain on study in the absence of disease progression or unacceptable toxicity for a maximum six cycles Toxicity assessments will be performed continuously DLT determination will be made based on adverse events AEs that occur during cycle 1 day 1-28 An expansion cohort of ten subjects at the maximum tolerated dose will occur at the conclusion of dose escalation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None