Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2
This is a prospective, multicenter, open-label, single-arm study to assess the efficacy, safety, and pharmacokinetics (PK) of IgPro20 in adults with hematologic malignancies treated with B-cell targeting Chimeric antigen receptor T-cell (CAR T-cell) and T-cell redirecting therapies (such as T-cell engager bispecific antibody \[TCE BsAb\] therapy). The primary objective is to demonstrate that true annualized rate of serious bacterial infection (SBIs) is less than (\<) 1.0. This study includes two cohorts: 1. Loading Cohort: Participants with serum immunoglobulin G (IgG) \< 500 milligrams per deciliter (mg/dL) at Screening, with or without ongoing immunoglobulin replacement therapy (IgRT) during Screening, who must have received five doses of IgPro20 during the Initial Treatment Period. 2. Maintenance-only Cohort: Participants with serum IgG greater than or equal to (≥) 500 mg/dL and ongoing IgRT at Screening, who must have received one dose of IgPro20 during the Initial Treatment Period.
About the trial
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Waga ciała co najmniej 40 kg.
- •Ostra białaczka, która nawróciła lub nie reaguje na leczenie, z pewnymi zmianami genetycznymi (KMT2A, NPM1, NUP98, NUP214), a dostępne metody leczenia zostały wyczerpane lub nie są odpowiednie dla pacjenta.
- •Ogólny stan zdrowia pozwalający na aktywność (stopień 0 lub 1 wg skali ECOG).
- •Regularne wypróżnienia (przynajmniej raz na 2 dni).
- •Kobiety w wieku rozrodczym muszą mieć negatywny wynik testu ciążowego przed rozpoczęciem leczenia.
✗ Disqualifies
- •Ostra białaczka promielocytowa lub białaczka związana z zespołem Downa.
- •Aktywne problemy z ośrodkowym układem nerwowym (mózg i rdzeń kręgowy).
- •Pacjenci po przeszczepach narządów.
- •Utrzymujące się lub ciężkie skutki uboczne wcześniejszych terapii przeciwnowotworowych (z wyjątkiem łysienia, stabilnej neuropatii obwodowej, małej liczby płytek krwi, neutropenii, anemii) lub powrót do stanu sprzed leczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 25, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.