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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
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 moreOther outcome measures
Incidence of leptomeningeal disease
Use of intrathecal prophylaxis
Side effects data
From 2011 Phase 3 trial • 867 Patients • NCT0064153724%
Back pain
20%
Neutropenia
12%
Hyperthermia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
6%
Weight decreased
6%
Hypertension
6%
Anxiety
6%
Uterine leiomyoma
6%
Respiratory tract infection viral
6%
Joint swelling
6%
Anaemia of pregnancy
6%
Viral upper respiratory tract infection
6%
Skin bacterial infection
6%
Dizziness
6%
Viral infection
6%
Arthralgia
6%
Infected insect bite
6%
Sinusitis
6%
Carpal tunnel syndrome
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
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,344 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,209 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
715 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with AML, acute biphenotypic leukemia, high risk MDS, or CML in myeloid blast phase.I can take care of myself but might not be able to do heavy physical work.I understand the study's requirements and have signed the consent form.I am using contraception or agree to use it during the study.I have leukemia and haven't had curative therapy; I may receive venetoclax.I do not have any uncontrolled illnesses.I have relapsed or refractory AML, acute biphenotypic leukemia, or CML in myeloid blast phase.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cladribine, cytarabine, idarubicin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Cladribine been granted endorsement by the Food and Drug Administration?
"Given the Phase 2 status of Cladribine, our staff at Power assigned it a score of 2 on the safety scale due to some data confirming its security but no evidence demonstrating its efficacy."
Answered by AI
Are there any vacancies for participation in this experiment?
"The clinicaltrials.gov listing confirms that this study is seeking participant enrolment at the time of writing; it was initially posted on May 19th 2014, with its most recent update occurring February 15th 2022."
Answered by AI
Does my profile qualify me to participate in this examination?
"This clinical trial is enlisting 458 subjects aged 18 to 65 who have been diagnosed with leukemia, myelogenous chronic BCR-ABL positive. For successful entry into the study, patients must meet a range of stipulations: A diagnosis of AML, acute biphenotypic leukemia or high risk MDS (>= 10% blasts or IPSS >= intermediate-2); no prior potentially curative therapy for leukaemia (aside from hydroxyurea, hematopoietic growth factors and other medications), ECOG performance status =< 2; and those eligible for venetoclax are assigned to frontline cohort"
Answered by AI
To what conditions is Cladribine typically prescribed?
"Cladribine is an oft-used drug to treat meningeal leukemia and other severe conditions, e.g. acute myeloid leukemia, pediatric blast phase chronic myelocytic leukemia, and acute myelocytic leukemia."
Answered by AI
Does the research permit participation from octogenarians?
"This research requires that participants are of legal age and under 65 years old."
Answered by AI
Are there any prior experiments that have been performed with Cladribine as a part of the treatment?
"Presently, there are 454 trials ongoing for Cladribine, with 92 of those being in Phase 3. Edmonton, Alberta is the primary location running these tests; however there are 17,566 sites executing studies on this medication."
Answered by AI
What is the aggregate amount of participants involved in this experiment?
"Indeed, clinicaltrials.gov affirms that this research is actively recruiting individuals as of now. This initiative was inaugurated on May 19th 2014 and its parameters were most recently adjusted on February 15th 2022. 458 participants are sought from a single medical facility."
Answered by AI
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