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OncoMatch/Clinical Trials/NCT05263284

8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia

Is NCT05263284 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including 8-Chloroadenosine and Venetoclax for acute myeloid leukemia.

Phase 1RecruitingCity of Hope Medical CenterNCT05263284Data as of May 2026

Treatment: 8-Chloroadenosine · VenetoclaxThis phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: salvage therapy — relapsed AML

Relapsed AML: Failed at least 1 line of salvage therapy

Must have received: induction chemotherapy — AML evolving from MDS or myeloproliferative disorder

AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy

Must have received: hypomethylating agent — AML evolving from MDS or myeloproliferative disorder

AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy

Lab requirements

Blood counts

White blood cell (WBC) <= 25 x 10^9/L prior to initiation of venetoclax

Kidney function

Creatinine clearance of >= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula

Liver function

Total bilirubin <= 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease); AST <= 2.5 x ULN; ALT <= 2.5 x ULN

Cardiac function

QTc <= 480 ms

White blood cell (WBC) <= 25 x 10^9/L prior to initiation of venetoclax. Total bilirubin <= 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease). Aspartate aminotransferase (AST) <= 2.5 x ULN. Alanine aminotransferase (ALT) <= 2.5 x ULN. Creatinine clearance of >= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula. QTc <= 480 ms.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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