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 to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic 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 evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowana przewlekła białaczka limfocytowa (lub chłoniak limfocytowy z małych komórek) zgodnie z najnowszymi kryteriami diagnostycznymi.
- •Dobra ogólna kondycja fizyczna pozwalająca na uczestnictwo w badaniu (oceniana w skali ECOG).
- •Widoczne powiększenie węzłów chłonnych w badaniu obrazowym (np. tomografii komputerowej).
✗ Disqualifies
- •Niekontrolowana niedokrwistość autoimmunohemolityczna lub małopłytkowość autoimmunohemolityczna, wymagająca leczenia sterydami.
- •Znane zaburzenia krzepnięcia krwi.
- •Udar mózgu lub krwawienie do mózgu w ciągu ostatnich 6 miesięcy.
- •Podejrzenie lub potwierdzona transformacja Richtera (przekształcenie białaczki w inny typ chłoniaka) lub zajęcie ośrodkowego układu nerwowego.
- •Ciężkie, aktywne choroby serca, takie jak niekontrolowane zaburzenia rytmu serca lub zaawansowana niewydolność serca.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 25, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (74)
The Oncology Institute Clinical Research
Cerritos, United States
Cancer and Blood Specialty Clinic
Los Alamitos, United States
SLO Oncology and Hematology Health Center
San Luis Obispo, United States
Providence Medical Foundation
Santa Rosa, United States
PIH Health Hospital
Whittier, United States
Grand Valley Oncology
Grand Junction, United States
Mount Sinai Medical Center Campus
Miami Beach, United States
The Oncology Institute
North Miami Beach, United States
Mid Florida Hematology Oncology
Orange, United States
Boise VA Medical Center
Boise, United States
Hope and Healing Cancer Services
Hinsdale, United States
Springfield Clinic
Springfield, United States
Iowa City VA Health Care System
Iowa City, United States
Minnesota Oncology Hematology P A
Minneapolis, United States
Research Medical Center
Kansas City, United States
Hunterdon Hematology Oncology
Flemington, United States
Summit Medical Group
Florham Park, United States
Hematology Oncology Associates of Rockland
Nyack, United States
Southeastern Medical Oncology Center
Goldsboro, United States
Oncology Hematology Care
Cincinnati, United States
Willamette Valley Cancer Institute and Research Center
Eugene, United States
OHSU Knight Cancer Institute
Portland, United States
Renovatio Clinical
El Paso, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Renovatio Clinical 1
The Woodlands, United States
Texas Oncology-Gulf Coast
The Woodlands, United States
Community Cancer Trials of Utah
Ogden, United States
Virginia Cancer Specialists
Manassas, United States
Virginia Oncology Associates
Virginia Beach, United States
VA Puget Sound Healthcare System
Seattle, United States
Northwest Cancer Specialists PC
Vancouver, United States
QEII Health Sciences Centre
Halifax, Canada
Niagara Health System
St. Catharines, Canada
Fakultni nemocnice Brno
Brno-Bohunice, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, Czechia
CHU de Clermont Ferrand
Clermont-Ferrand, France
CHU Nantes
Nantes, France
Hopital Pitie Salpetriere
Paris, France
CHU Lyon Sud
Pierre-Bénite, France
CHU de Reims
Reims, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France
Semmelweis Egyetem
Budapest, Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary
University of Szeged
Szeged, Hungary
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale San Raffaele
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale Maggiore della Carita
Novara, Italy
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy
Ospedale Villa Sofia-Cervello
Palermo, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
Umberto I Policlinico di Roma
Roma, Italy
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, Poland
Szpitale Pomorskie Sp z o o
Gdynia, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Reina Sofia
Córdoba, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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