← Back to Search

Antimetabolite

Questionnaire Administration for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Geoffrey L Uy
Research Sponsored by National Cancer Institute (NCI)
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 time from registration to death (up to 10 years)
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat AML in older patients. Sorafenib tosylate may stop cancer cell growth by blocking enzymes needed for cell growth. Chemotherapy drugs used in this trial work in different ways to stop the growth of cancer cells. This combination of drugs may be an effective treatment for AML.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Acute Promyelocytic Leukemia
  • Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from registration to death (up to 10 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from registration to death (up to 10 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
Overall Survival (OS) Rate
Secondary outcome measures
Event-free Survival
OS

Side effects data

From 2020 Phase 3 trial • 177 Patients • NCT01817075
13%
Rash maculo-papular
10%
Skin and subcutaneous tissue disorders - Other, specify
1%
Mucositis oral
1%
Sepsis
1%
Skin ulceration
1%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (CHG Cleansing Wipe)
Arm II (Control)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (daunorubicin, cytarabine, sorafenib tosylate)Experimental Treatment8 Interventions
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate orally every 12 hours on days 1-7. CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28. MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Biopsy
2014
Completed Phase 4
~850
Sorafenib Tosylate
2005
Completed Phase 3
~4010
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,613 Total Patients Enrolled
Geoffrey L UyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
670 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Blood AdvancesJournal
Evaluation of Event-free Survival as a Robust End Point in Untreated Acute Myeloid Leukemia (alliance A151614)
Yin, Jun, Betsy LaPlant, Geoffrey L. Uy, Guido Marcucci, William Blum, Richard A. Larson, Richard M. Stone, and Sumithra J. Mandrekar. 2019. “Evaluation of Event-free Survival as a Robust End Point in Untreated Acute Myeloid Leukemia (alliance A151614)”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2018026112.
Journal of Hematology & OncologyJournal
A Precision Medicine Classification for Treatment of Acute Myeloid Leukemia in Older Patients
Mims, Alice S., Jessica Kohlschmidt, Uma Borate, James S. Blachly, Shelley Orwick, Ann-Kathrin Eisfeld, Dimitrios Papaioannou, et al.. 2021. “A Precision Medicine Classification for Treatment of Acute Myeloid Leukemia in Older Patients”. Journal of Hematology & Oncology. Springer Science and Business Media LLC. doi:10.1186/s13045-021-01110-5.
clinicaltrials.govStudy
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
2011. "Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01253070.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top