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Anti-metabolites

Combination Chemotherapy for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Tapan M Kadia

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 a diagnosis of AML, acute biphenotypic leukemia, or high risk MDS (>= 10% blasts or International Prognostic Scoring System [IPSS] >= intermediate-2) will be eligible; patients with CML in myeloid blast phase are also eligible

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well 4 different drugs work to treat leukemia, myelodysplastic syndrome, or blastic phase chronic myeloid leukemia.

Who is the study for?

This trial is for adults with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Eligible participants must have certain levels of liver and kidney function, a heart ejection fraction >= 45%, an ECOG performance status of =< 2 (which means they can do some activities), and no severe allergies to the drugs used. Pregnant or breastfeeding women cannot join, and participants must agree to use contraception.

What is being tested?

The study tests how well a combination of chemotherapy drugs—cladribine, idarubicin, cytarabine—and venetoclax work in treating specific blood cancers. It's designed to see if these drugs can stop cancer cells from growing by killing them or preventing their division and spread.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as allergies, effects on fertility due to required contraception use during the trial period, potential harm to unborn children leading to exclusion of pregnant women from participation, and general chemotherapy-related side effects like fatigue, nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with AML, acute biphenotypic leukemia, high risk MDS, or CML in myeloid blast phase.

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I can take care of myself but might not be able to do heavy physical work.

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I have relapsed or refractory AML, acute biphenotypic leukemia, or CML in myeloid blast phase.

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

Complete response (CR) rate

Secondary study objectives

Duration of response

Event-free survival (EFS)

Incidence of toxicities

+2 more

Other study objectives

Incidence of leptomeningeal disease

Use of intrathecal prophylaxis

Side effects data

From 2011 Phase 3 trial • 867 Patients • NCT00641537

24%

Back pain

20%

Neutropenia

12%

Lymphopenia

12%

Influenza like illness

12%

Fatigue

12%

Influenza

12%

Hyperthermia

Depression

Carpal tunnel syndrome

Viral upper respiratory tract infection

Uterine leiomyoma

Upper respiratory tract infection

Pain in extremity

Headache

Arthralgia

Anxiety

Hypertension

Anaemia of pregnancy

Eye irritation

Eye pruritus

Gastrooesophageal reflux disease

Hypersensitivity

Respiratory tract infection viral

Viral infection

Herpes zoster

Sinusitis

Infected insect bite

Skin bacterial infection

Contusion

Joint sprain

Liver function test abnormal

Weight decreased

Dizziness

Joint swelling

Pharyngolaryngeal pain

Cough

Restless legs syndrome

Pregnancy

Depressed mood

Abortion threatened

Iron deficiency anaemia

Erythema infectiosum

Tooth disorder

Faecal incontinence

Injection site abscess

White blood cell count decreased

Sensation of heaviness

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cladribine 3.5 mg/kg/No Treatment

Cladribine 5.25 mg/kg/No Treatment

Cladribine Low/Placebo (LLPP)

Cladribine High Dose/Placebo (HLPP)

Cladribine Low/Low Dose (LLLL)

Cladribine High/Low Dose (HLLL)

Placebo/Cladribine Low Dose (PPLL)

Placebo/No Treatment

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 (cladribine, cytarabine, idarubicin)Experimental Treatment7 Interventions

INDUCTION: Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-5 and idarubicin IV over 30-60 minutes on days 1-3. Patients with untreated AML and MDS also receive venetoclax PO on days 2-8. AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD on days 1-14. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-3 and idarubicin IV over 30-60 minutes on days 1-2. Patients with untreated AML and MDS also receive venetoclax PO on days 2-8. AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cladribine

2014

Completed Phase 4

~4650

Cytarabine

2016

Completed Phase 3

~3330