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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 below

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I have AML or high-risk MDS without prior treatment.

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My liver and kidney functions are within normal limits and I can care for myself.

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I have AML and haven't been treated or eligible for other AML clinical trials.

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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:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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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

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

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Hyponatremia

Hypoxia

Myalgia

Depression

Immune system disorders - Other, specify

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

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

~4650

Cytarabine

2016

Completed Phase 3

~3330