Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06811233
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
Status:
RECRUITING
Status Verified Date:
2025-10
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:
The goal of this clinical research study is to learn if metal detoxification (with calcium disodium edetate \[Ca-EDTA\] and dimercaptosuccinic acid \[DMSA\]) during standard therapy can help improve outcomes in patients with intermediate-risk, high-risk, or secondary AML compared to standard therapy alone. Researchers think lowering the level of metals found in the blood/bone marrow may help to control the disease and/or improve the response to chemotherapy.
Detailed Description:
Primary Objective:
To compare event free survival of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
Secondary Objectives:
Compare the remission rates and overall survival rates of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to those receiving standard therapy alone.
* To assess the efficacy information regarding the combined therapy in terms of the overall response rate (ORR) including CR, CRh, CRi, MLFS, and PR in patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy and in patients with secondary, intermediate and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
* To compare adverse events of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated), secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
* To assess the complete remission (CR), complete remission with incomplete hematologic recovery (CRi), Complete Remission with Partial hematological recovery (CRh), partial remission (PR), hematologic improvement (HI), morphologic leukemia free state (MLFS) rates, and the overall survival (OS) in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving cancer therapy alone.
* To assess overall survival and event free survival in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone To assess remission duration in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone.
* To monitor toxic and essential metal levels during AML therapy combined with DMSA and Ca-EDTA and to evaluate the reduction in metals in the bone marrow and blood of newly diagnosed AML patients undergoing metal detoxification combined with standard AML therapy.
* Correlate metal and copper isotopic abundance ratios of AML patients with clinical data, conventional cytogenetics, extensive Next Generation Sequencing (NGS) (300-gene panel), exposure survey data, and clinical outcome data, and to perform a larger analysis by pooling this data with metal/genomic/survey/outcome data obtained on 2017-0752, 2017-0937 and PA15-0302.
* To assess other responses of interest in Measurement of Effect Section
To compare event free survival of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
Secondary Objectives:
Compare the remission rates and overall survival rates of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to those receiving standard therapy alone.
* To assess the efficacy information regarding the combined therapy in terms of the overall response rate (ORR) including CR, CRh, CRi, MLFS, and PR in patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy and in patients with secondary, intermediate and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
* To compare adverse events of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated), secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
* To assess the complete remission (CR), complete remission with incomplete hematologic recovery (CRi), Complete Remission with Partial hematological recovery (CRh), partial remission (PR), hematologic improvement (HI), morphologic leukemia free state (MLFS) rates, and the overall survival (OS) in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving cancer therapy alone.
* To assess overall survival and event free survival in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone To assess remission duration in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone.
* To monitor toxic and essential metal levels during AML therapy combined with DMSA and Ca-EDTA and to evaluate the reduction in metals in the bone marrow and blood of newly diagnosed AML patients undergoing metal detoxification combined with standard AML therapy.
* Correlate metal and copper isotopic abundance ratios of AML patients with clinical data, conventional cytogenetics, extensive Next Generation Sequencing (NGS) (300-gene panel), exposure survey data, and clinical outcome data, and to perform a larger analysis by pooling this data with metal/genomic/survey/outcome data obtained on 2017-0752, 2017-0937 and PA15-0302.
* To assess other responses of interest in Measurement of Effect Section
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00860 | OTHER | NCI-CTRP Clinical Trials Registry | View |