Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492707
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
DR-18 for the Treatment of Relapsed or Persistent Acute Myeloid Leukemia or Myelodysplastic Syndrome After Hematopoietic Cell Transplantation the DR DREAM Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Decoy-Resistant Interleukin-18 DR-18 for Relapse or Pre-emptive Treatment of Measurable Residual Disease After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome DR DREAM
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety side effects and best dose of decoy-resistant interleukin-18 DR-18 and how well it works in treating patients with acute myeloid leukemia AML or myelodysplastic syndrome MDS that has come back after a period of improvement relapsed or that remains despite treatment persistent after hematopoietic cell transplantation HCT HCT is the only curative therapy for most forms of AML and MDS However relapse occurs in a third of patients and is the most common cause of death after HCT DR-18 a variant of the human cytokine interleukin-18 binds to IL-18 binding probein IL-18BP and overcomes the inhibitory effect of the IL-18BP on IL-18 which may boost the bodys immune system and may interfere with the ability of tumor cells to grow and spread Giving DR-18 may be safe tolerable andor effective in treating patient with relapsed or persistent AML or MDS after HCT
Detailed Description:
OUTLINE This is a dose-escalation study
INDUCTION Patients receive DR-18 subcutaneously SC once weekly on approximately days 0 7 14 and 21
MAINTENANCE Two weeks after induction treatment patients without grade 3-4 acute GVHD grade 2 acute GVHD requiring ongoing systemic immunosuppression or moderatesevere chronic GVHD may receive DR-18 SC once weekly on approximately days 35 42 49 and 56
Additionally patients undergo blood and bone marrow sample collection throughout the study
After completion of study treatment patients are followed weekly for 4 weeks monthly through 6 months and at 12 months
INDUCTION Patients receive DR-18 subcutaneously SC once weekly on approximately days 0 7 14 and 21
MAINTENANCE Two weeks after induction treatment patients without grade 3-4 acute GVHD grade 2 acute GVHD requiring ongoing systemic immunosuppression or moderatesevere chronic GVHD may receive DR-18 SC once weekly on approximately days 35 42 49 and 56
Additionally patients undergo blood and bone marrow sample collection throughout the study
After completion of study treatment patients are followed weekly for 4 weeks monthly through 6 months and at 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04811 | REGISTRY | None | None |
| FH20254 | OTHER | None | None |