NCT07423104

A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloid Leukemia

Not yet recruiting Phase 2 Last updated 20 February 2026

What this trial tests

Phase 2 trial testing CAV in Acute Myeloid Leukemia (AML) in 24 participants. Not yet recruiting.

Timeline

15 August 2026

Primary endpoint
1 February 2029

1 February 2030

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	15 August 2026
Primary completion	1 February 2029
Estimated completion	1 February 2030

Drugs / interventions tested

• CAV — full drug profile →

Conditions studied

• Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute myeloid leukemia (AML) is a bone marrow cancer that is challenging to treat. It is the most common type of acute leukemia, particularly in adults. There are around 20,000 cases of acute myeloid leukemia diagnosed in the United States every year. Despite the recent significant progress in the understanding of acute myeloid leukemia leading to the development of new therapies, significant challenges remain. The initial treatment for acute myeloid leukemia involves using therapies aimed at reducing the disease burden in the bone marrow to the lowest possible level (a state known as disease remission). This is usually followed by consolidation treatment aimed at curing the disease. The initial treatment involves high intensity chemotherapy in younger adults who can tolerate these therapies and low intensity therapies for older adults or those with other medical conditions that prohibit them from receiving high intensity chemotherapy. The consolidation therapy involves either more chemotherapy or a bone marrow transplant. In the recent years, a treatment regimen consisting of two drugs; Azacytidine and Venetoclax has become the standard of care for low intensity therapy intended for older adults. Despite significant improvement in outcomes of acute myeloid leukemia in older adults after the introduction of Azacytidine/Venetoclax, yet 40% of patients who receive this treatment will either be refractory to it or relapse after an initial remission. Those whose leukemia relapses after Azacytidine/Venetoclax treatment are left with very few treatment options and have a dismal prognosis. Based on previous laboratory studies, certain subtypes of acute myeloid leukemia tend to not respond as well to Azacytidine/Venetoclax therapy and have a better chance of responding to the treatment regimen the investigators are proposing in this study. The study treatment regimen consists of 3 drugs; Cladribine, low dose Cytarabine and Venetoclax. Demonstrating efficacy of the study regimen in treatment of relapsed/refractory acute myeloid leukemia, after prior Venetoclax therapy, will provide another treatment option for those with a relapsed/refractory disease who wish to continue receiving therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.