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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

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with AML, acute biphenotypic leukemia, high risk MDS, or CML in myeloid blast phase.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have relapsed or refractory AML, acute biphenotypic leukemia, or CML in myeloid blast phase.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate
Secondary outcome measures
Duration of response
Event-free survival (EFS)
Incidence of toxicities
+2 more
Other outcome measures
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%
Hyperthermia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
6%
Carpal tunnel syndrome
6%
Weight decreased
6%
Uterine leiomyoma
6%
Hypertension
6%
Anxiety
6%
Joint swelling
6%
Anaemia of pregnancy
6%
Viral upper respiratory tract infection
6%
Dizziness
6%
Arthralgia
6%
Respiratory tract infection viral
6%
Sinusitis
6%
Infected insect bite
6%
Skin bacterial infection
6%
Viral infection
6%
Depressed mood
6%
Pharyngolaryngeal pain
6%
Cough
6%
Joint sprain
6%
Eye irritation
6%
Upper respiratory tract infection
6%
Headache
6%
Depression
6%
Restless legs syndrome
6%
Pain in extremity
6%
Eye pruritus
6%
Contusion
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Pregnancy
6%
Herpes zoster
6%
Liver function test abnormal
6%
Abortion threatened
6%
Iron deficiency anaemia
6%
Erythema infectiosum
6%
Tooth disorder
6%
Faecal incontinence
6%
Injection site abscess
6%
White blood cell count decreased
6%
Sensation of heaviness
6%
Syncope
100%
80%
60%
40%
20%
0%
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

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
Gilteritinib
2014
Completed Phase 2
~560
Midostaurin
2018
Completed Phase 3
~1640
Cladribine
2014
Completed Phase 4
~4390
Cytarabine
2016
Completed Phase 3
~3310
Idarubicin
2014
Completed Phase 4
~4330
Venetoclax
2019
Completed Phase 3
~1950

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,147 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,622 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
755 Total Patients Enrolled

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02115295 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (cladribine, cytarabine, idarubicin)
Acute Myeloid Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT02115295 — Phase 2
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02115295 — Phase 2
~42 spots leftby May 2025