Actively Recruiting
Cladribine Venetoclax in Monocytic AML
Led by University of Colorado, Denver · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax
CONDITIONS
Official Title
Cladribine Venetoclax in Monocytic AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of non-acute promyelocytic leukemia AML with monocytic or monoblastic phenotype or Ras pathway mutation
- AML relapsed or refractory after prior treatment with hypomethylating agent and venetoclax combination
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate kidney function with creatinine clearance of 60 mL/min or higher
- Adequate liver function with AST and ALT less than or equal to 3 times the upper limit of normal, and bilirubin less than or equal to 1.5 times upper limit of normal (or up to 4 times in Gilbert's syndrome)
- Non-sterile male subjects must use contraception during treatment and for 90 days after last dose, and agree to refrain from sperm donation during this time
- Female subjects must be postmenopausal, permanently surgically sterile, or use contraception during treatment and for 6 months after last dose
- Signed informed consent prior to any study procedures
You will not qualify if you...
- Prior treatment with cladribine for AML
- White blood cell count greater than 25 x 10^9/L (hydroxyurea or leukapheresis allowed to meet this requirement)
- Known active central nervous system involvement of AML
- Uncontrolled systemic infection needing therapy
- Clinically significant conditions that would interfere with study participation, including heart failure worse than NYHA class 2, or serious renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular, or bleeding disorders
- QTc interval greater than 470 msec
- History of other malignancies within 2 years except certain treated cancers like in situ breast or cervical carcinoma, basal or localized squamous cell skin carcinoma, surgically resected malignancies with curative intent, or prostate cancer not requiring treatment beyond hormones
- Pregnancy or breastfeeding
- Known HIV positive status
- Known hepatitis B or C infection unless viral load is undetectable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universtiy of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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