Phase 2
N=37
Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT04848974 ↗Enrolled (actual)
37
Serious AEs
56.8%
Results posted
Oct 2025
Primary outcome: Primary: Recommended Phase II Dose — 5 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cladribine (Drug); Cytarabine (Drug); Uproleselan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase II Dose |
5 | — |
| SECONDARY Number of Participants With a Response |
1; 4; 9 | — |
| SECONDARY Number of Participants With Complete Response (CR) |
0; 2; 2 | — |
| SECONDARY Number of Participants With Complete Remission Without Blood Count Recovery (CRi) |
0; 1; 5 | — |
| SECONDARY Number of Participants to Reach Morphologic Leukemia-free State (MLFS) |
1; 1; 2 | — |
| SECONDARY Number of Minimal Residual Disease (MRD) Negativity in Responders |
1; 2; 2 | — |
| SECONDARY Overall Survival |
0.8; 5.5; 3.8 | — |
| SECONDARY Complete Remission Duration |
— | — |
| SECONDARY Event-free Survival |
0.6; 3.1; 1.7 | — |
| SECONDARY The Number of Participants With Complete Cytogenetic Response (CCyR) |
1; 1; 2 | — |
| SECONDARY Induction Mortality, Number of Participants |
0; 0; 4 | — |
Summary
This phase Ib/II trial finds out the best dose and effect of cladribine and low dose cytarabine when given in combination with uproleselan in treating patients with treated secondary acute myeloid leukemia. Chemotherapy drugs, such as uproleselan, cladribine, and low dose cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible.
- TS-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm that has been previously treated with hypomethylating agents).
- Patients must be at least 7 days from their last therapy for the antecedent myeloid neoplasm
- Age >/= 18 years.
- Adequate organ function as defined below:
- liver function (total bilirubin or = 45% within the past 6 months
- ECOG performance status of ≤ 2.
- A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
- Patient must have the ability to understand the requirements of the study and informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.
Exclusion Criteria
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with documented hypersensitivity to any of the components of the chemotherapy program.
- 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.
- Prior treatment with uproleselan.
- Patients with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.
Data sourced from ClinicalTrials.gov (NCT04848974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.