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Anti-metabolites

Genomic Assessment for Mutation Clearance in Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Meagan Jacoby, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-60 years
Has previously untreated, de novo, non-M3 AML with intermediate-risk disease (Intermediate-I or Intermediate-II) as defined by ELN criteria OR normal cytogenetics with mutated NPM1 without FLT3-ITD. Monoallelic CEBPA mutations are not considered favorable risk and are therefore eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare the relapse-free and overall survival of patients with leukemia who have cleared their leukemia-associated mutations after standard consolidation chemotherapy to historical controls. The trial will also compare the relapse-free and overall survival of patients who have not cleared their mutations.

Who is the study for?
This trial is for adults aged 18-60 with previously untreated, non-M3 Acute Myeloid Leukemia (AML) of intermediate risk or normal cytogenetics with specific mutations. Participants must be in remission post-induction therapy and agree to use contraception. Excluded are those with AML due to prior chemo/radiation, other hematological malignancies, significant medical issues affecting compliance, known HIV/HBV/HCV infections, or pregnancy.Check my eligibility
What is being tested?
The study tests if clearing leukemia-associated mutations using standard chemotherapy improves survival compared to historical data. It also assesses outcomes for patients whose mutations persist and may receive either chemotherapy or a stem cell transplant based on the physician's discretion.See study design
What are the potential side effects?
Potential side effects include reactions related to bone marrow procedures, skin biopsy discomforts, risks from genetic sequencing like learning about heritable mutations, complications from cytarabine such as blood disorders and organ damage, and transplant-related risks like graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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My AML is untreated, not M3 type, and is intermediate-risk or has specific genetic features.
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My blood cancer is in remission but my blood counts haven't fully recovered.
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I have received chemotherapy to kill cancer cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse free survival of Cohort A compared to intermediate risk historical control group
Secondary outcome measures
Compare overall survival of Cohort A to Cohort B
Compare relapse free survival of Cohort A to Cohort B
Overall survival (OS) of Cohort A compared intermediate risk historical control group
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Investigator's choice (HiDAC, AlloSCT)Experimental Treatment5 Interventions
At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq Patients who have persistent leukemia-associated mutations, defined as a LAM VAF ≥2.5% will be assigned to the investigator's choice arm. Patients assigned to this arm may received either HiDAC or AlloSCT. HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, & 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI. The source of stem cell product, donor selection, conditioning regimen, graft-versus-host-prophylaxis, and supportive care will be at the discretion of the treatment physician For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician.
Group II: Cohort A: HiDACExperimental Treatment4 Interventions
At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq Patients who have clearance of their leukemia-associated mutations, defined as a LAM VAF <2.5% will be assigned to the high-dose cytarabine consolidation (HiDAC) arm. HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, & 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI. For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone marrow aspiration
2000
Completed Phase 2
~260
Punch skin biopsy
2018
N/A
~60
Cytarabine
2016
Completed Phase 3
~3310
Allogeneic stem cell transplant
2005
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,618 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,024 Total Patients Enrolled
American Society of HematologyOTHER
11 Previous Clinical Trials
20,751 Total Patients Enrolled

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02756962 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Cohort B: Investigator's choice (HiDAC, AlloSCT), Cohort A: HiDAC
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT02756962 — Phase 2
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02756962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what end is Cytarabine typically employed?

"Cytarabine is typically employed in the management of leptomeningeal metastases, but has also proven efficacious for conditions such as acute promyelocytic leukemia, meningeal leukemia, and blast phase chronic myelocytic leukemia."

Answered by AI

Do you accept participants who are of senior age for this experiment?

"According to the specified regulations for this medical experiment, individuals must be aged 18 or older and no more than 60 years of age."

Answered by AI

What is the highest capacity of this medical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this medical research has been open for recruitment since July 6th 2016 and was recently updated on August 30th 2022. The project is looking to enlist 100 participants from 3 distinct sites."

Answered by AI

Is recruitment still available for the trial participants?

"Affirmative. According to the records on clinicaltrials.gov, this medical research project is actively seeking out volunteers and has been since July 6th 2016. The trial requires 100 participants at 3 separate centres and was last updated in August 30th 2022."

Answered by AI

What potential hazards may arise from utilizing Cytarabine?

"Although there is preliminary evidence of safety, no data suggesting efficacy yet exists. Therefore, Cytarabine has been rated a 2 on the Power scale."

Answered by AI

Could you please enumerate the prior investigations that have dealt with Cytarabine?

"Currently, there are 234 clinical trials being conducted with Cytarabine. Out of these studies, 60 have reached Phase 3 testing and the bulk of them are located in New york City; however, 9789 locations worldwide have opened their doors to research involving this medication."

Answered by AI

Are there any prerequisites for participating in this research study?

"The trial requires 100 patients aged 18 - 60 suffering from untreated, de novo, non-M3 Acute Myelocytic Leukemia with intermediate risk or normal cytogenetics combined with mutated NPM1 but without FLT3-ITD. Monoallelic CEBPA mutations are accepted despite being unfavorable in order to qualify for participation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance
2016. "Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02756962.
~58 spots leftby Jul 2033
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