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Anti-metabolites

Sorafenib for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Anna Halpern
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will study the side effects of filgrastim, cladribine, cytarabine, and mitoxantrone given with sorafenib, and to find the best dose of these drugs to treat patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Biphenotypic Leukemia
  • Myeloproliferative Neoplasms
  • Myelodysplastic Syndrome

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
Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Mitoxantrone
Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Sorafenib
Phase I and II: Rate of Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Secondary outcome measures
Complete Remission (CR)
Event-free Survival (EFS)
Number of Participants With Adverse Events
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib, G-CLAM)Experimental Treatment7 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3670
Sorafenib
2014
Completed Phase 3
~1670
Mitoxantrone
2008
Completed Phase 3
~1510
Cytarabine
2016
Completed Phase 3
~3310
Cladribine
2014
Completed Phase 4
~4390

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,229 Previous Clinical Trials
25,325,353 Total Patients Enrolled
University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,233 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,562 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers looking for more participants at this time?

"According to the latest update on clinicaltrials.gov, this study is not recruiting patients at the moment. This trial was initially posted on December 1st, 2016 but was updated as recently as February 7th, 2022. Although this study isn't looking for participants now, there are 3413 other trials that are currently enrolling patients."

Answered by AI

If I qualify, can I take part in this experiment?

"Eligibility for this leukeamia clinical trial requires patients to be between 18-60 years old, have a TRM score of 13.1 or lower, an ejection fraction of 45% or higher, and meet other conditions as indicated."

Answered by AI

Is this the first time Sorafenib has been trialed?

"Currently, 463 trials are running that investigate the efficacy of Sorafenib. Out of those 463 studies, 117 are in Phase 3. Many of the Sorafenib trials originate from Taibei, Taiwan; however, there are 15274 locations worldwide where these investigations are taking place."

Answered by AI

What is the most well-known use for Sorafenib?

"Sorafenib is most often used in procedures like hemopoietic stem cell transplantation and bone marrow transplants. Additionally, this medication can be employed in diagnostic imaging and to fight infection."

Answered by AI

Does this test exclude patients that are above a certain age?

"This particular clinical trial only enrolls patients that are between 18-60 years old. Out of the nearly 4,500 other trials, 968 were for people under 18 and 2,553 were for adults over 65."

Answered by AI

How many people are signed up to participate in this study?

"This study is not recruiting patients at this time. It was initially posted on December 1st, 2016 and received its last update on February 7th, 2022. If you are interested in other studies, there are 2950 clinical trials related to leukemia and 463 involving Sorafenib currently looking for participants."

Answered by AI
~10 spots leftby Mar 2025