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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

No Placebo-Only Group

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.

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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.

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I can take care of myself and am up and about more than half of my waking hours.

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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:

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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.

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I have never had serious irregular heartbeats.

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I have severe heart failure.

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I have congenital long QT syndrome.

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My family has a history of long QT syndrome.

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I am currently taking medication that strongly affects liver enzyme activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Dysgeusia

Hyponatremia

Pneumonia

Insomnia

Musculoskeletal pain

Anxiety

Arthralgia

Muscle spasms

Dyspepsia

Pain

Urinary tract infection

Hypoalbuminemia

Graft versus host disease in skin

Upper respiratory tract infection

Sepsis

Blood alkaline phosphatase increased

Blood creatinine increased

Gingival bleeding

Abdominal pain upper

Hyperglycemia

Dysuria

Skin lesion

Graft versus host disease

Chills

Contusion

Leukocytosis

Pruritis

Myalgia

Pleural effusion

Dry mouth

Dry eye

Leukopenia

Abdominal distension

Device related infection

Hypertension

Nasal congestion

Neutropenic sepsis

Sinus tachycardia

Confusional state

Proctalgia

Cellulitis

Septic shock

Hemorrhage intracranial

Bacteremia

Graft versus host disease in intestine

Syncope

Staphylococcal infection

Escherichia sepsis

Skin infection

Acute febrile neutrophilic dermatosis

Rash generalized

Cerebral hemorrhage

Clostridium difficile infection

Klebsiella sepsis

Lung infection

Pneumonia fungal

Staphylococcal bacteremia

Hematuria

Atrial fibrillation

Pericarditis

Pneumonitis

Respiratory failure

Pancytopenia

Enterobacter infection

Infection

Gastroenteritis

Neutropenic infection

100%

80%

60%

40%

20%

Study treatment Arm

Quizartinib

Salvage Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4650