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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML.

The goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.

Eligibility criteria

Qualifiers

Provision of written informed consent prior to any study related procedures.

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)

Disqualifiers

Uncontrolled intercurrent illness including, but not limited to 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.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the compounds in the study.

Legal incapacity or limited legal capacity.

Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation.

Trial design

Treatments tested in this trial

  • Cytarabine
  • Oral Cladribine

Treatment groups

58 Participants
are divided into 1 treatment group

Sponsors and collaborators