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Phase 1b/2 Study of Oral Cladribine for Acute Myeloid Leukemia (AML)

This study is testing a new combination of medicines for Acute Myeloid Leukemia (AML), a type of blood cancer. It involves oral cladribine, cytarabine, and venetoclax. The first part of the study aims to find the safest and most effective dose of oral cladribine when given with these other drugs. The second part will then see if this dose helps control the disease in patients with newly diagnosed AML. You may be able to join if you are 18 or older and have relapsed (returned) or refractory (not responding to treatment) AML, or newly diagnosed AML after a prior diagnosis of Myelodysplastic Syndromes (MDS). The study is looking to enroll about 58 participants, but its current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It is a dose-ranging study, starting with finding the right dose and then testing its effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be monitored throughout the study, which is expected to last an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07053020

A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~58 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:CytarabineOral Cladribine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Acute Myeloid Leukemia (AML)

Explore related trials

Acute Myeloid LeukemiaRAS Family Oncogene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Gautam Borthakur, MBBS · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Gautam Borthakur, MBBS
[email protected]
(713) 563-1586
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Serum creatinine . 2.0xupper limit of normal (ULN)
Serum total bilirubin .2xULN (with the exception of patients with known Gilbert's syndrome: serum total bilirubin must be \<3xULN in these patients)
Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) .2.5xULN or .5xULN if due to leukemic involvement) 4. Adequate cardiac function with a left ventricular ejection fraction .50% 5. Female participants are eligible to enter and participate in the study if they are of nonchildbearing potential. Female participants of childbearing age must use at least 2 forms of effective birth control during the study treatment period and for at least 90 days after the last dose of investigational product. 6. Male participants are eligible to enter and participate in the study if they agree to use effective methods of contraception during the study treatment period and for at least 90 days after the last dose of investigational product.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0