Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02995655
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2016-12-13
Brief Title:
CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Pilot Study of CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2019-12
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:
None
Brief Summary:
The investigators hypothesize that CX-01 will disrupt the bone marrow microenvironment and increase the cytotoxic effects of azacitidine on myelodysplastic syndrome MDS and acute myeloid leukemia AML hematopoietic stem cells by disrupting the High-mobility group box protein 1 HMGB1 interaction with toll-like receptor 4 TLR4 and receptors for advanced glycation end products RAGE the CXC chemokine CXCL12chemokine receptor 4 CXCR4 axis and by disrupting other leukocyte and vascular adhesion molecules In addition CX-01 may also help promote count recovery after treatment given its affinity for platelet factor-4 PF4
The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based upon the dual requirements to have sufficient drug administered to have potential activity but without clinically significant anticoagulation The study dose chosen 4 mgkg bolus followed by 025 mgkghour fulfills both of these criteria In addition this dose is expected to result in serum levels of CX-01 which are significantly higher than the IC90 identified in preclinical studies for inhibition of HMGB1-RAGE toll-like receptor 2 TLR2 and TLR4 interaction Therefore the chosen dose represents a rational balance between effective dosing and safety in thrombocytopenic patients with MDS and AML This dose was previously established to be safe and tolerable when combined with cytarabine and idarubicin in patients with AML
The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based upon the dual requirements to have sufficient drug administered to have potential activity but without clinically significant anticoagulation The study dose chosen 4 mgkg bolus followed by 025 mgkghour fulfills both of these criteria In addition this dose is expected to result in serum levels of CX-01 which are significantly higher than the IC90 identified in preclinical studies for inhibition of HMGB1-RAGE toll-like receptor 2 TLR2 and TLR4 interaction Therefore the chosen dose represents a rational balance between effective dosing and safety in thrombocytopenic patients with MDS and AML This dose was previously established to be safe and tolerable when combined with cytarabine and idarubicin in patients with AML
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CNTX-CX-01-2016-MDS-1 | OTHER | Cantex Pharmaceuticals | None |