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Anti-metabolites

Trametinib for Acute Myelogenous Leukemia

Phase 2
Waitlist Available
Led By Nicholas Short
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they're effective in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Refractory Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Complete remission(CR)/complete remission without recovery of counts (CRi) (Cohort B)
Overall survival (Cohort A)
Secondary outcome measures
Complete response rate
Event-free survival
Minimal residual disease negativity
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, venetoclax, trametinib)Experimental Treatment3 Interventions
INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Azacitidine
FDA approved
Venetoclax
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,781 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,646 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
165 Total Patients Enrolled

Frequently Asked Questions

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

Could you provide a brief overview of other research projects that have used Azacitidine?

"Azacitidine is being researched in 444 separate clinical trials. Of these, 61 are large-scale Phase 3 studies. The majority of research sites for Azacitidine are located in Edmonton, Alberta; however, there are 17085 different trial locations worldwide."

Answered by AI

What are we hoping to learn from this clinical trial?

"The primary outcome of this clinical trial is complete remission (CR) / complete remission without recovery of counts (CRi). This will be measured over a From the first day of treatment to time of death from any cause, assessed at 1 year time frame. Secondary outcomes include Minimal residual disease negativity, Relapse-free survival, and Complete response rate."

Answered by AI

Are there any upcoming vacancies in this trial for new participants?

"The most recent information on clinicaltrials.gov suggests that this trial is actively looking for patients to participate. The listing was created on 7/21/2020, with the date of 1/13/2021 denoting the most recent update."

Answered by AI

What is the standard treatment that involves azacitidine?

"Azacitidine is most often used as part of an induction chemotherapy regimen. Additionally, it has shown efficacy in treating refractory anemias, metastatic melanoma, and unresectable melanoma."

Answered by AI

How many individuals can take part in this clinical trial at one time?

"Yes, that is correct. The listing on clinicaltrials.gov reveals that this study is actively recruiting patients. This trial was first posted on July 21st 2020 and has been updated as recently as January 13th 2021. Currently, the research team is looking to enroll 40 patients from a single site."

Answered by AI

Could you explain the health risks associated with Azacitidine?

"Azacitidine is still being tested for efficacy in Phase 2 trials, but there is some data supporting its safety--so it received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome
2020. "Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04487106.
~4 spots leftby Apr 2025
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