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Antimetabolite

Dasatinib for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Guido Marcucci
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
Emergency treatment for hyperleukocytosis with hydroxyurea
Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new chemotherapy drug to treat AML patients. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
30 Day Survival Rate
Secondary outcome measures
Complete Response Rate
Cumulative Incidence of Death
Cumulative Incidence of Relapse
+3 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046
26%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Typhlitis
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Oropharyngeal pain
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Atrial fibrillation
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (daunorubicin hydrochloride, cytarabine, dasatinib)Experimental Treatment4 Interventions
INDUCTION THERAPY (course 1): Patients receive daunorubicin hydrochloride IV on days 1-3, cytarabine IV continuously over 168 hours on days 1-7, and dasatinib PO QD on days 8-21. Patients with responsive disease on day 21 undergo consolidation therapy, and patients with non-responsive disease on day 21 (bone marrow cellularity >= 20% and leukemia blasts >= 5%) receive a second course of induction therapy. INDUCTION THERAPY (course 2): Patients receive daunorubicin hydrochloride IV on days 1-3, cytarabine IV continuously over 120 hours on days 1-5, and dasatinib PO QD on days 6-19. Patients achieving complete response receive consolidation therapy. CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3, and 5, and dasatinib PO QD on days 6-26 or 7-27. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Dasatinib
2012
Completed Phase 3
~2320
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,585 Total Patients Enrolled
Guido MarcucciPrincipal InvestigatorAlliance for Clinical Trials in Oncology
7 Previous Clinical Trials
703 Total Patients Enrolled

Frequently Asked Questions

~4 spots leftby Mar 2025