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Quizartinib for Myelodysplastic Syndrome

Phase 1 & 2
Waitlist Available
Led By Yesid Alvarado, MD
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 12 months
Awards & highlights

Study Summary

This trial is studying quizartinib in combination with azacitidine or cytarabine to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • FLT3-ITD Positive
  • Chronic Myelomonocytic Leukemia
  • FLT3 Gene Mutation Negative
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of Quizartinib (Phase I)
Participants With a Response
Secondary outcome measures
Incidence of adverse events (Phase II)

Side effects data

From 2020 Phase 3 trial • 367 Patients • NCT02039726
47%
Nausea
37%
Pyrexia
36%
Anemia
33%
Vomiting
32%
Hypokalemia
28%
Diarrhea
28%
Fatigue
26%
Thrombocytopenia
26%
Electrocardiogram QT prolonged
23%
Cough
21%
Febrile neutropenia
21%
Edema peripheral
21%
Headache
20%
Decreased appetite
20%
Dyspnea
20%
Neutropenia
20%
Constipation
16%
Stomatitis
15%
Hypomagnesemia
15%
Rash
15%
Dizziness
15%
White blood cell count decreased
14%
Asthenia
14%
Platelet count decreased
13%
Hypotension
13%
Alanine aminotransferase increased
13%
Neutrophil count decreased
12%
Epistaxis
12%
Abdominal pain
11%
Weight decreased
11%
Hypocalcemia
11%
Aspartate aminotransferase increased
11%
Petechiae
11%
Back pain
10%
Hypophosphatemia
10%
Blood bilirubin increased
10%
Oropharyngeal pain
10%
Pain in extremity
9%
Dysgeusia
9%
Hyponatremia
9%
Pneumonia
9%
Insomnia
8%
Musculoskeletal pain
8%
Anxiety
8%
Arthralgia
8%
Muscle spasms
8%
Dyspepsia
8%
Pain
7%
Urinary tract infection
7%
Hypoalbuminemia
7%
Graft versus host disease in skin
7%
Upper respiratory tract infection
7%
Sepsis
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
7%
Gingival bleeding
7%
Abdominal pain upper
6%
Hyperglycemia
6%
Dysuria
6%
Skin lesion
6%
Graft versus host disease
6%
Chills
6%
Contusion
6%
Leukocytosis
6%
Pruritis
6%
Myalgia
6%
Pleural effusion
5%
Dry mouth
5%
Dry eye
5%
Leukopenia
5%
Abdominal distension
4%
Device related infection
4%
Hypertension
4%
Nasal congestion
3%
Neutropenic sepsis
3%
Sinus tachycardia
3%
Confusional state
3%
Proctalgia
2%
Cellulitis
2%
Septic shock
2%
Hemorrhage intracranial
2%
Bacteremia
2%
Graft versus host disease in intestine
2%
Syncope
2%
Staphylococcal infection
1%
Escherichia sepsis
1%
Skin infection
1%
Acute febrile neutrophilic dermatosis
1%
Rash generalized
1%
Cerebral hemorrhage
1%
Clostridium difficile infection
1%
Klebsiella sepsis
1%
Lung infection
1%
Pneumonia fungal
1%
Staphylococcal bacteremia
1%
Hematuria
1%
Atrial fibrillation
1%
Pericarditis
1%
Pneumonitis
1%
Respiratory failure
1%
Pancytopenia
1%
Enterobacter infection
1%
Infection
1%
Gastroenteritis
1%
Neutropenic infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quizartinib
Salvage Chemotherapy

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 Arm II (quizartinib, cytarabine)Experimental Treatment1 Intervention
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Phase 2 Arm I (quizartinib, azacitidine)Experimental Treatment2 Interventions
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Phase 1 Arm II (quizartinib, cytarabine)Experimental Treatment2 Interventions
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Phase 1 Arm I (quizartinib, azacitidine)Experimental Treatment2 Interventions
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Azacitidine
2012
Completed Phase 3
~1440
Quizartinib
2016
Completed Phase 3
~1110

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,844 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,646 Previous Clinical Trials
40,930,954 Total Patients Enrolled
Yesid Alvarado, MDPrincipal InvestigatorM.D. Anderson Cancer Center

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
clinicaltrials.govStudy
Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
2013. "Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01892371.
~6 spots leftby Apr 2025
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