Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01241500
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2010-11-01
Brief Title:
Randomized Study of ON 01910Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
Sponsor:
Traws Pharma Inc
Organization:
Traws Pharma Inc
Study Overview
Official Title:
Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONTIME
Brief Summary:
The primary objective of this study is to compare overall survival OS in patients receiving ON 01910Na best supportive care BSC to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome MDS with excess blasts 5 to 30 bone marrow blasts who have failed azacitidine or decitabine treatment This patient population has no available therapy and a short life expectancy approximately 4 months The high level of bone marrow activity of ON 01910Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid LeukemiaAML a very significant and severe complication which shortens survival of these MDS patients
Detailed Description:
This is a Phase III open-label randomized controlled multicenter study up to 50 centers Approximately 270 patients with MDS classified as RAEB-1 and RAEB-2 using the WHO classification and as RAEB-t and chronic myelomonocytic leukemia CMML using the FAB classification who failed became intolerant to or progressed after treatment with 5-azacitidine or decitabine administered during the past 2 years will be randomized in a 21 ratio into the following 2 treatment regimens
Best Supportive Care BSC ON 01910Na 1800 mg24 hr administered as a 72-hr continuous intravenous CIV infusion on Days 1 2 and 3 of a 2-week cycle N approximately 180 patients
BSC N approximately 90 patients
Patients will be stratified at entry by bone marrow BM blasts 5 to 19 vs 20 to 30 After completing the first eight 2-week cycles ie after 16 weeks of treatment the frequency of further 72-hr CIV infusions will be decreased to an administration on Days 1 2 and 3 of a 4-week cycle
Patients will remain treated on study until 2006 International Working Group IWG progression criteria are met ie 50 increase of BM blasts or worsening of cytopenias or until death from any cause whichever comes first
Patients who progress to Acute Myeloid Leukemia AML while on study should be offered either standard treatment for AML or enrollment in an appropriate investigational study if they are eligible These treatments with their start and end dates should be documented and patient survival time will be documented for all randomized patients
Cross-over of BSC patients to ON 01910Na after progression will not be allowed However patients in the BSC-only group will be allowed as medically justified access to low-dose cytarabine 20 mgm2 subcutaneously SC once daily for the first consecutive 14 days of each 28-day cycle up to 4 cycles until progression or unacceptable toxicity develops Low-dose cytarabine will be delayed as needed until recovery of blood counts All study participants will be allowed as medically justified access to RBC and platelet transfusions and to growth factors erythropoietin Filgrastim G-CSF Hydroxyurea will be allowed to manage blastic crisis with hyperleukocytosis when patients transition to leukemia
Best Supportive Care BSC ON 01910Na 1800 mg24 hr administered as a 72-hr continuous intravenous CIV infusion on Days 1 2 and 3 of a 2-week cycle N approximately 180 patients
BSC N approximately 90 patients
Patients will be stratified at entry by bone marrow BM blasts 5 to 19 vs 20 to 30 After completing the first eight 2-week cycles ie after 16 weeks of treatment the frequency of further 72-hr CIV infusions will be decreased to an administration on Days 1 2 and 3 of a 4-week cycle
Patients will remain treated on study until 2006 International Working Group IWG progression criteria are met ie 50 increase of BM blasts or worsening of cytopenias or until death from any cause whichever comes first
Patients who progress to Acute Myeloid Leukemia AML while on study should be offered either standard treatment for AML or enrollment in an appropriate investigational study if they are eligible These treatments with their start and end dates should be documented and patient survival time will be documented for all randomized patients
Cross-over of BSC patients to ON 01910Na after progression will not be allowed However patients in the BSC-only group will be allowed as medically justified access to low-dose cytarabine 20 mgm2 subcutaneously SC once daily for the first consecutive 14 days of each 28-day cycle up to 4 cycles until progression or unacceptable toxicity develops Low-dose cytarabine will be delayed as needed until recovery of blood counts All study participants will be allowed as medically justified access to RBC and platelet transfusions and to growth factors erythropoietin Filgrastim G-CSF Hydroxyurea will be allowed to manage blastic crisis with hyperleukocytosis when patients transition to leukemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None