Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474663
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
A Phase I Study Investigating the Combination of Cladribine Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study Investigating the Combination of Cladribine Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
To find the recommended dose of the drug combination cladribine cytarabine decitabine and sorafenib in participants with relapsedrefractory AML MPAL and ALAL
Detailed Description:
Primary Objectives - To determine the safety tolerability and recommended phase II dose RP2D of the combination of cladribine low-dose cytarabine sorafeneib alternating with decitabine for pediatric participants with acute leukemias
Secondary Objectives
- To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with partial hematological recovery CRh CR with incomplete blood count recovery CRi Morphologic leukemia free state MLFS and partial remission PR overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
Secondary Objectives
- To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with partial hematological recovery CRh CR with incomplete blood count recovery CRi Morphologic leukemia free state MLFS and partial remission PR overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
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 |
|---|---|---|---|
| NCI-2024-05386 | OTHER | None | None |