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Anti-metabolites
Cladribine + LDAC + Decitabine for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase 2
Recruiting
Led By Tapan Kadia, 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
Patients with previously untreated AML or high risk MDS (>/= 10 % blasts or IPSS >/= intermediate-2).
Adequate organ function: liver function (bilirubin < 2mg/dL, AST and/or ALT <3 x ULN), kidney function (creatinine < 1.5 x ULN), ECOG performance status of ≤ 2.
Must not have
Uncontrolled intercurrent illness including ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of drugs as a potential treatment for AML or MDS.
Who is the study for?
This trial is for adults aged 18 or older with untreated AML or high-risk MDS, who are not suitable for standard therapy. Participants must understand the study and consent to it, have adequate organ function, and agree to use contraception. Pregnant women, those with uncontrolled illnesses or hypersensitivity to the drugs used in this trial cannot participate.
What is being tested?
The study tests a combination of Cladribine, Cytarabine (LDAC), and Decitabine on patients with AML or MDS. It aims to see if these drugs can control the disease by interfering with cancer cells' DNA processing and repair mechanisms. Up to 160 participants will be enrolled at MD Anderson.
What are the potential side effects?
Potential side effects may include damage to DNA leading to cell death which could cause symptoms like fatigue, nausea, infections due to low blood counts, liver dysfunction indicated by elevated bilirubin levels, and other organ-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML or high-risk MDS without prior treatment.
Select...
My liver and kidney functions are within normal limits and I can care for myself.
Select...
I have AML and haven't been treated or eligible for other AML clinical trials.
Select...
My creatinine or bilirubin levels are high, or I am mostly bedridden.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I am using or willing to use contraception during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease-Free Survival (DFS)
Side effects data
From undefined Phase 3 trial • 1734 Patients • NCT0002525980%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Immune system disorders - Other, specify
1%
Depression
1%
Hyponatremia
1%
Hypoxia
1%
Myalgia
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)
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: Cladribine + Cytarabine Alt. with DecitabineExperimental Treatment3 Interventions
Induction cycle: Cladribine intravenous (IV) over approximately 1 to 2 hours, daily on days 1-5 combined with Cytarabine subcutaneous (SQ) twice daily on days 1-10. Cytarabine should be administered approximately 3-6 hours following the start of the cladribine infusion.
Consolidation cycle: Cladribine IV over 1 to 2 hours, daily on days 1-3 combined with Cytarabine SQ twice daily on days 1-10. Cytarabine should be administered 3-6 hours following the start of the cladribine infusion.
Alternating with: Decitabine IV over 1 to 2 hours, daily on days 1-5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
2014
Completed Phase 4
~4410
Cytarabine
2016
Completed Phase 3
~3330
Decitabine
2004
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,064 Total Patients Enrolled
464 Trials studying Leukemia
31,639 Patients Enrolled for Leukemia
Tapan Kadia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
497 Total Patients Enrolled
3 Trials studying Leukemia
486 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have AML or high-risk MDS without prior treatment.I have previously been treated with specific medications like hydroxyurea or azacytidine.I have AML that evolved from MDS and haven't had AML treatment before.My liver and kidney functions are within normal limits and I can care for myself.I understand the study's requirements and have signed the consent form.I have taken decitabine before, but my condition didn't worsen to AML during treatment.I have AML and haven't been treated or eligible for other AML clinical trials.I am 18 or older and standard cancer treatment is not suitable for me.My creatinine or bilirubin levels are high, or I am mostly bedridden.I am using or willing to use contraception during the study.I am 60 years or older, or under 60 but cannot undergo standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cladribine + Cytarabine Alt. with Decitabine
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.
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