NCT04848974CompletedPhase 1/2
Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia
Phase Ib/II Study of Uproleselan Added to Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed by Consolidation With Uproleselan Plus Cladribine Plus LDAC in Patients With Treated Secondary AML (TS-AML)
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 5 Apr 2021
- Start date
- 11 Jun 2021
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04848974
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 37
- From 11 Jun 2021 to the primary completion date, 30 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
Other
- Patients with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.
Who the study is looking for
- 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 \< 2mg/dL, AST and/or ALT \<3 x ULN - or \<5 x ULN if related to leukemic involvement)
- kidney function (creatinine \< 1.5 x ULN ).
- known cardiac ejection fraction of \> 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.