Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289673
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-23
Brief Title:
Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic LeukemiaLymphoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
INITIALL Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic LeukemiaLymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 goal of this study is to provide sufficient therapy during the time a patients B-cell Acute Lymphoblastic Leukemia ALL or Lymphoblastic Leukemia LLy risk category is being determined The term risk refers to the chance of the ALL or LLy coming back after treatment
Primary Objectives
To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemialymphoma and mixed phenotype acute leukemialymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies
To develop a central database of genomic and clinical findings
Secondary Objectives
To assess event free and overall survival data of patients enrolled on this study
Primary Objectives
To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemialymphoma and mixed phenotype acute leukemialymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies
To develop a central database of genomic and clinical findings
Secondary Objectives
To assess event free and overall survival data of patients enrolled on this study
Detailed Description:
Patients with newly diagnosed acute lymphoblastic leukemia lymphoma ALLLLy and mixed phenotype acute leukemia lymphoma MPAL will undergo diagnostic procedures either during screening or on Day 1 They will receive 7 days of chemotherapy including 13 doses of dexamethasone 1 dose of vincristine and 1 dose of daunorubicin for patients with T-ALLLLy or MPAL only Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy After the completion of 7 days of chemotherapy patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy
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-2024-01659 | REGISTRY | NCI Clinical Trial Registration Program | None |