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Anti-metabolites
Combination Chemotherapy for Chronic Myelomonocytic Leukemia & Myelodysplastic Syndrome
Phase 2
Recruiting
Led By Guillermo Bravo, MD
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
Diagnosis of MDS or CMML by WHO
Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it can help control higher-risk myelodysplastic syndrome or chronic myelomonocytic leukemia.
Who is the study for?
Adults with higher-risk chronic myelomonocytic leukemia (CMML) or myelodysplastic syndromes (MDS) who have not responded to previous treatments. Participants must be over 18, have a white blood cell count under 50,000/L, and an ECOG performance status of <=2. They should also have adequate kidney and liver function and agree to use contraception if they can reproduce.Check my eligibility
What is being tested?
The trial is testing whether a combination of drugs—cladribine, cytarabine, venetoclax, and azacitidine—is effective in controlling higher-risk MDS with excess blasts or CMML. It aims to find out if this drug regimen can help patients who haven't had success with other therapies.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems; fatigue; liver issues; kidney dysfunction; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MDS or CMML.
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I can take care of myself and perform daily activities.
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My liver is functioning well.
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My MDS is high risk and didn't improve after 6 treatment cycles.
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My MDS is high risk with more than 10% blasts or newly diagnosed.
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I am 18 years old or older.
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My CMML did not improve after 6 treatments or it got worse.
Select...
I have CMML and haven't received HMA treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the overall survival (OS).
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%
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%
Sinusitis
6%
Carpal tunnel syndrome
6%
Infected insect bite
6%
Uterine leiomyoma
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: cladribine, cytarabine, venetoclax, and azacitidineExperimental Treatment4 Interventions
Participants will receive cladribine, cytarabine, and venetoclax for 2 cycles and then azacitidine and venetoclax for 2 cycles. Participants will repeat this pattern of 2 cycles each for up to a total of 18
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
FDA approved
Cytarabine
FDA approved
Venetoclax
FDA approved
Azacitidine
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,257 Total Patients Enrolled
Guillermo Bravo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MDS or CMML.I can take care of myself and perform daily activities.My liver is functioning well.I am not pregnant or have confirmed it with a test.I have a history of HIV.My MDS is high risk and didn't improve after 6 treatment cycles.My MDS is high risk with more than 10% blasts or newly diagnosed.I am 18 years old or older.My heart's pumping ability is significantly reduced.My CMML did not improve after 6 treatments or it got worse.I have CMML and haven't received HMA treatment.I have an infection that isn't getting better with antibiotics.I have had a recent heart attack or unstable chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: cladribine, cytarabine, venetoclax, and azacitidine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Are there any openings currently available for this clinical experiment?
"Affirmative, according to the clinicaltrials.gov registry this study is open for recruitment. It was initially posted on September 23rd 2022 and has since been amended as recently as October 31st 2022. The trial needs 60 patients from 1 site to complete its research."
Answered by AI
How many participants have been included in this research study thus far?
"Affirmative. Clinicaltrials.gov exhibits evidence that this trial, which was initially listed on September 23rd 2022 is currently accepting patients. The study requires 60 participants to be enrolled from 1 medical site."
Answered by AI
Has the U.S. Food and Drug Administration authorized Cladribine for usage?
"Given the limited clinical data that has been collected on Cladribine so far, our team at Power rated its safety a 2. This indicates there is some documentation of safety but no proof yet of efficacy."
Answered by AI
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