← Back to Search

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 for reporting.

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 • NCT00025259
80%
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

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01515527 — Phase 2
Leukemia Research Study Groups: Cladribine + Cytarabine Alt. with Decitabine
Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT01515527 — Phase 2
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01515527 — Phase 2
~13 spots leftby Feb 2026