Quizartinib for Biphenotypic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Biphenotypic Leukemia+7 MoreQuizartinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the side effects and effectiveness of combining four drugs to treat patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Eligible Conditions
  • Biphenotypic Leukemia
  • Myelodysplastic Syndrome
  • Acute Recurrent Myeloid Leukemia
  • Refractory Acute Myelogenous Leukemia
  • Aplastic Anemia
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 12 months

Month 12
Change in the presence of other gene mutations
Change of FLT3 ligand level
Month 12
Event free survival (EFS)
Up to 12 months
Disease free survival (DFS)
Incidence of adverse events
Overall survival (OS)
Rate of response

Trial Safety

Side Effects for

Quizartinib
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%Dyspnea
20%Decreased appetite
20%Neutropenia
20%Constipation
16%Stomatitis
15%Dizziness
15%Hypomagnesemia
15%Rash
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%Aspartate aminotransferase increased
11%Weight decreased
11%Hypocalcemia
11%Petechiae
11%Back pain
10%Pain in extremity
10%Blood bilirubin increased
10%Hypophosphatemia
10%Oropharyngeal pain
9%Pneumonia
9%Dysgeusia
9%Hyponatremia
9%Insomnia
8%Anxiety
8%Dyspepsia
8%Muscle spasms
8%Musculoskeletal pain
8%Pain
8%Arthralgia
7%Urinary tract infection
7%Hypoalbuminemia
7%Upper respiratory tract infection
7%Graft versus host disease in skin
7%Sepsis
7%Blood alkaline phosphatase increased
7%Blood creatinine increased
7%Gingival bleeding
7%Abdominal pain upper
6%Dysuria
6%Chills
6%Contusion
6%Leukocytosis
6%Skin lesion
6%Pruritis
6%Myalgia
6%Hyperglycemia
6%Graft versus host disease
6%Pleural effusion
5%Dry mouth
5%Dry eye
5%Leukopenia
5%Abdominal distension
4%Hypertension
4%Nasal congestion
4%Device related infection
3%Sinus tachycardia
3%Neutropenic sepsis
3%Confusional state
3%Proctalgia
2%Cellulitis
2%Hemorrhage intracranial
2%Bacteremia
2%Septic shock
2%Graft versus host disease in intestine
2%Syncope
2%Staphylococcal infection
1%Skin infection
1%Cerebral hemorrhage
1%Rash generalized
1%Clostridium difficile infection
1%Lung infection
1%Klebsiella sepsis
1%Staphylococcal bacteremia
1%Pneumonia fungal
1%Acute febrile neutrophilic dermatosis
1%Hematuria
1%Atrial fibrillation
1%Pericarditis
1%Pneumonitis
1%Respiratory failure
1%Pancytopenia
1%Enterobacter infection
1%Escherichia sepsis
1%Infection
1%Gastroenteritis
1%Neutropenic infection
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02039726) in the Quizartinib ARM group. Side effects include: Nausea with 47%, Pyrexia with 37%, Anemia with 36%, Vomiting with 33%, Hypokalemia with 32%.

Trial Design

1 Treatment Group

Treatment (idarubicin, cladribine, cytarabine, quizartinib)
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Quizartinib · No Placebo Group · Phase 1 & 2

Treatment (idarubicin, cladribine, cytarabine, quizartinib)Experimental Group · 4 Interventions: Cytarabine, Cladribine, Idarubicin, Quizartinib · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Cladribine
FDA approved
Idarubicin
FDA approved
Quizartinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,804 Previous Clinical Trials
1,790,398 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,076 Previous Clinical Trials
41,139,468 Total Patients Enrolled
1 Trials studying Biphenotypic Leukemia
44 Patients Enrolled for Biphenotypic Leukemia
Musa YilmazPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
104 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a diagnosis of ovarian cancer.
You are aged 18 to 65 years.
You are in the ECOG performance status of 0, 1, or 2.
Creatinine is < 1.5 mg/dl.\n
You have a relapse cohort of patients aged ≥18 years old.