← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

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.

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.Check my eligibility

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.See study design

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

Select...

My cancer is a type of leukemia affecting areas outside the bone marrow.

Select...

I have been diagnosed with Acute biphenotypic leukemia.

Select...

I have AML, acute biphenotypic leukemia, or high-risk MDS that has come back or didn't respond to treatment.

Select...

I am between 18 and 65 years old.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event free survival (EFS)

Incidence of adverse events

Secondary outcome measures

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

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

~3310

Cladribine

2014

Completed Phase 4

~4390

Quizartinib

2016

Completed Phase 3

~1110

Idarubicin

2014

Completed Phase 4

~4330

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,310 Total Patients Enrolled

6 Trials studying Aplastic Anemia

244 Patients Enrolled for Aplastic Anemia

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,774 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the intended outcomes of this experiment?

"The primary endpoint of this clinical trial, assessed over a 12-month period from start treatment until event or death, is the occurrence of adverse events. Secondary objectives include Disease Free Survival (DFS) which will be estimated using Kaplan Meier analysis, Change in presence of other gene mutations calculated through summary statistics and patient cohorts, as well as Rate of Response to each 28-gene panel mutation for individual patient cohorts."

Answered by AI

Is this medical trial currently accessible to individuals seeking treatment?

"Clinicaltrials.gov confirms that this medical trial is actively recruiting, having first been posted on October 22nd 2019 and recently updated on September 30th 2022."

Answered by AI

In what clinical circumstances is Quizartinib typically administered?

"Quizartinib is generally prescribed for acute myeloid leukemia in children. However, it can also be utilized to treat a multitude of other conditions such as blast phase chronic myelocytic leukemia and human ctage1 protein-associated leukemia."

Answered by AI

Are there any other investigations into Quizartinib that have been conducted?

"Presently, there are 257 trials involving Quizartinib in progress. Of those ongoing studies, 65 have entered into Phase 3 of the research process. Most of these clinical experiments are situated within New york City; however, 10141 other sites around the world are assessing this potential remedy."

Answered by AI

How many participants comprise the current clinical trial?

"Affirmative. Documents on clinicaltrials.gov elucidate that this research endeavour, initiated on October 22nd 2019, is now seeking out 80 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

2019. "Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04047641.

All > Aplastic Anemia