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Antimetabolite

Combination Chemotherapy for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Musa Yilmaz
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
Patients with isolated extramedullary myeloid neoplasm will be eligible
Diagnosis of Acute biphenotypic leukemia
Must not have
- Sustained ventricular tachycardia requiring medical intervention
Impaired cardiac function including any of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with newly diagnosed, relapsed, or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Eligible participants are those aged 18-65 who haven't had certain chemotherapies, have a good performance status, functioning organs, and no serious concurrent illnesses. Women of childbearing potential must test negative for pregnancy and use contraception.
What is being tested?
The trial tests the effectiveness and side effects of combining chemotherapy drugs cladribine, idarubicin, cytarabine with quizartinib in patients with AML or MDS. It aims to see if this combination can help control these diseases by killing cancer cells or stopping their growth.
What are the potential side effects?
Potential side effects include damage to the heart muscle leading to heart failure; gastrointestinal issues that might affect drug absorption; blood disorders like anemia; increased risk of infections due to immune system suppression; liver problems indicated by elevated bilirubin levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of leukemia affecting areas outside the bone marrow.
Select...
I have been diagnosed with Acute biphenotypic leukemia.
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I have AML, acute biphenotypic leukemia, or high-risk MDS that has come back or didn't respond to treatment.
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I am between 18 and 65 years old.
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My diagnosis is high-risk MDS with more than 10% bone marrow blasts.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with AML, not including a specific type called Acute promyelocytic leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a fast heart rate that needed treatment.
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My heart does not function properly.
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I have not had major surgery in the last 14 days.
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I have been diagnosed with HIV or active viral hepatitis.
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I have a serious gut problem that affects how my body absorbs medicine.
Select...
I have never had serious irregular heartbeats.
Select...
I have severe heart failure.
Select...
I have congenital long QT syndrome.
Select...
My family has a history of long QT syndrome.
Select...
I am currently taking medication that strongly affects liver enzyme activity.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event free survival (EFS)
Incidence of adverse events
Secondary study objectives
Change in the presence of other gene mutations
Change of FLT3 ligand level
Disease free survival (DFS)
+2 more

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

1Treatment groups
Experimental Treatment
Group I: Treatment (idarubicin, cladribine, cytarabine, quizartinib)Experimental Treatment4 Interventions
INDUCTION: Patients receive idarubicin Intravenous over 1 hours on days 1-3, cladribine intravenous over 1-2 hours on days 1-5, cytarabine Intravenous over 3 hours on days 1-5 (or days 1-3 for patients over age 60), and quizartinib by mouth daily on days 6-19. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR or CRp after Induction receive idarubicin Intravenous over 1 hours on days 1-2, cladribine Intravenous over 1-2 hours on days 1-3, cytarabine Intravenous over 3 hours on days 1-3, and quizartinib by mouth daily on days 4-28. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients who achieve CR or CRi/CRh after Consolidation receive quizartinib by mouth daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles 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
~3330
Cladribine
2014
Completed Phase 4
~4410
Quizartinib
2016
Completed Phase 3
~1110
Idarubicin
2014
Completed Phase 4
~4330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,621 Total Patients Enrolled
6 Trials studying Aplastic Anemia
244 Patients Enrolled for Aplastic Anemia
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,920 Total Patients Enrolled
8 Trials studying Aplastic Anemia
1,038 Patients Enrolled for Aplastic Anemia
Musa YilmazPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

Cladribine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04047641 — Phase 1 & 2
Aplastic Anemia Research Study Groups: Treatment (idarubicin, cladribine, cytarabine, quizartinib)
Aplastic Anemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04047641 — Phase 1 & 2
Cladribine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04047641 — Phase 1 & 2
~16 spots leftby Dec 2025
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